Knee Replacement Surgery, Osteoarthritis
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
Interventions
PROCEDUREStandard of Care
Conventional hemostatic techniques, such as cautery and manual compression, will be used.
DRUGFLOSEAL Hemostatic Matrix + Standard of care
FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes. \+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant is 18 to 80 years of age inclusive at the time of screening * Participant is planned for primary unilateral total knee arthroplasty * Participant has signed the informed consent form * Participant is in stable health (i.e., able to undergo surgery and participate in a follow-up program based on physical examination and medical history) * Participant has a preoperative Hgb level \> 10 g/dL * If female of childbearing potential, the participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study * Participant is willing and able to comply with the requirements of the protocol
Exclusion criteria
* Participant has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months * Participant has osteonecrosis or arthrotomy within the last year * Participant has prior or current hardware in target knee * Participant has had injections in the knee: 1. Steroids within the 3 months prior to scheduled surgery, 2. Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery * Participant has had general surgery within 3 months * Participant has rheumatoid arthritis or any other inflammatory or traumatic bone injuries to the knee within the 12 months prior to scheduled surgery * Participant has allergies to products of bovine origin * Participant has a history of bleeding, platelet, or bone marrow disorders * Participant has donated more than 1 unit of blood donation in the 3 weeks prior to surgery * Participant has a history of a coagulation disorder * Participant is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin (Lovenox) * Participant has been treated with aspirin or Warfarin (Coumadin) or clopidogrel (Plavix) within 7 days prior to surgery * Participant is not permitted to remain without his/her anti-coagulant regimen (e.g. Plavix) for 48 hours postoperatively * Participant has taken nonsteroidal anti-inflammatory agents or herbal supplements within 7 days of surgery * Participant has a history of substance abuse (alcohol, drugs) or is an active smoker * Participant has liver cirrhosis * Participant has erythropoietin agonist/stimulating agent within 90 days prior to surgery * Participant has an active infection or previous history of infection in the affected joint within the previous 6 months * Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively | Pre-operative and 2 days post-operatively | — |
| Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) | Throughout the study period, 1 year and 4 months | * Proportion of Participants who have serious injuries (SIs) related to IP * Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hematocrit (Hct) at Postoperative Day 1 | Pre-operative and day 1 post-operatively | Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels. |
| Change From Baseline in Hematocrit (Hct) at Postoperative Day 2 | Pre-operative and day 2 post-operatively | — |
| Change From Baseline in Hematocrit (Hct) at Postoperative Day 3 | Pre-operative and day 3 post-operatively | — |
| Total Tourniquet Time | Intra-operatively (on day of surgery = Day 0) | Measured from the time point of the tourniquet inflation to deflation using the same watch/clock |
| Amount of FLOSEAL Applied | Intra-operatively (Day 0) | — |
| Duration of Surgery | Time from first incision to complete wound closure (Day 0) | — |
| Transfusion Requirements - Packed Red Blood Cells | Intra-operatively (Day 0) thru Postoperative Day 3 | — |
| Total Drain Output at Day 1 Post-operatively | 1 day post-operatively | — |
| Pain Management - Number of Days When Pain Medication Was Used | Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6 | Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis. While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary. |
| Visual Analogue Scale (VAS) Pain Scores | Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. |
| Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3 | Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. |
| Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1 | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. |
| Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2 | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. |
| Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6 | Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6 | Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain. |
| Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6 | A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues) Postoperative (Postop) |
| Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively | Pre-operative and day 1 post-operatively | — |
| Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Preoperative, and Postoperative Weeks 1, 2, and 6 | Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. |
| Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Baseline and Postoperative Weeks 1, 2, and 6 | Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores). |
| Length of Hospital Stay | From the day of hospitalization to the day of discharge | — |
| Proportion of Participants With Transfusion Requirements | Intra-operative | — |
| Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage) | Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6 | — |
| Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery | Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6 | — |
| Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | 60 days | The number of participants responding affirmative in their rehabilitation diaries for each day |
| Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6 | A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues). Postoperative (Postop) |
| Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively | Pre-operative and day 3 post-operatively | Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 12 clinical sites in the United States, beginning October 2011
Pre-assignment details
137 participants were enrolled and screened. 5 were screen failures. 14 withdrew prior to surgery (1 physician decision, 4 study terminated, 8 withdrawn by participant, 1 sponsor educator not available). 12 were run-in participants. Therefore, 106 of the 137 enrolled were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SoC) SoC: conventional hemostatic techniques such as cautery and manual compression | 53 |
| FLOSEAL + Standard of Care (SoC) - Non-Run-In FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression | 53 |
| FLOSEAL + Standard of Care (SoC) - Run-In Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression | 12 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Missed week 6 assessments | 1 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care (SoC) | FLOSEAL + Standard of Care (SoC) - Non-Run-In | FLOSEAL + Standard of Care (SoC) - Run-In | Total |
|---|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 8.09 | 64.8 years STANDARD_DEVIATION 7.73 | 59.4 years STANDARD_DEVIATION 8.49 | 64.8 years STANDARD_DEVIATION 8.14 |
| Region of Enrollment United States | 53 participants | 53 participants | 12 participants | 118 participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 7 Participants | 65 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 5 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 65 | 3 / 53 |
| serious Total, serious adverse events | 4 / 65 | 6 / 53 |
Outcome results
Primary
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
Time frame: Pre-operative and 2 days post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively | -3.73 g/dL | Standard Deviation 1.497 |
| FLOSEAL + Standard of Care (SoC) | Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively | -3.70 g/dL | Standard Deviation 1.205 |
p-value: 0.453one-sided, two-sample t-test
Primary
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
* Proportion of Participants who have serious injuries (SIs) related to IP * Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP
Time frame: Throughout the study period, 1 year and 4 months
Population: Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) | Participants who have SIs related to IP | 0.00 Proportion of participants |
| Standard of Care (SoC) | Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) | Participants who have non-SAEs related to IP | 0.02 Proportion of participants |
| FLOSEAL + Standard of Care (SoC) | Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) | Participants who have SIs related to IP | 0.00 Proportion of participants |
| FLOSEAL + Standard of Care (SoC) | Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) | Participants who have non-SAEs related to IP | 0.00 Proportion of participants |
Secondary
Amount of FLOSEAL Applied
Time frame: Intra-operatively (Day 0)
Population: Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Amount of FLOSEAL Applied | 18.1 mL | Standard Deviation 5.52 |
Secondary
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues). Postoperative (Postop)
Time frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Stiffness (N= 41, 40) | -0.2 score on a scale | Standard Deviation 6.36 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Total Score (N= 25, 28) | -55.5 score on a scale | Standard Deviation 46.91 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Total Score (N= 18, 24) | -22.0 score on a scale | Standard Deviation 57.04 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Pain (N= 49, 47) | -18.3 score on a scale | Standard Deviation 10.46 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Pain (N= 41, 41) | -3.2 score on a scale | Standard Deviation 11.54 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Stiffness (N= 49, 46) | -6.5 score on a scale | Standard Deviation 5.54 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Pain (N= 41, 43) | -11.2 score on a scale | Standard Deviation 10.9 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Physical Functioning (N= 42, 40) | -63.6 score on a scale | Standard Deviation 38.27 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Physical Functioning (N= 18, 24) | -16.7 score on a scale | Standard Deviation 42.58 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Average (N= 42, 39) | -3.6 score on a scale | Standard Deviation 2.16 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Stiffness (N= 41, 42) | -3.8 score on a scale | Standard Deviation 5.84 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Total Score (N= 42, 39) | -87.0 score on a scale | Standard Deviation 51.8 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Total Score (N= 15, 16) | 0.0 score on a scale | Standard Deviation 51.66 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Pain (N= 46, 42) | -7.3 score on a scale | Standard Deviation 12.72 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Physical Functioning (N= 26, 28) | -40.3 score on a scale | Standard Deviation 33.65 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Stiffness (N= 46, 42) | -1.7 score on a scale | Standard Deviation 5.79 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Average (N= 18, 24) | -0.9 score on a scale | Standard Deviation 2.38 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Physical Functioning (N= 15, 16) | 4.7 score on a scale | Standard Deviation 39.93 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Average (N= 25, 28) | -2.3 score on a scale | Standard Deviation 1.95 |
| Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Average (N= 15, 16) | -0.0 score on a scale | Standard Deviation 2.15 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Average (N= 25, 28) | -1.0 score on a scale | Standard Deviation 2.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Total Score (N= 15, 16) | 19.2 score on a scale | Standard Deviation 54.7 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Pain (N= 41, 41) | -3.2 score on a scale | Standard Deviation 10.23 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Stiffness (N= 41, 40) | 0.5 score on a scale | Standard Deviation 6.05 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Physical Functioning (N= 18, 24) | -7.3 score on a scale | Standard Deviation 44.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Average (N= 18, 24) | -0.3 score on a scale | Standard Deviation 2.28 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 1: Total Score (N= 18, 24) | -6.2 score on a scale | Standard Deviation 54.6 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Pain (N= 41, 43) | -7.8 score on a scale | Standard Deviation 11.98 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Stiffness (N= 41, 42) | -1.7 score on a scale | Standard Deviation 6.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Physical Functioning (N= 26, 28) | -18.7 score on a scale | Standard Deviation 43.74 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Average (N= 15, 16) | 0.8 score on a scale | Standard Deviation 2.28 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 2: Total Score (N= 25, 28) | -24.5 score on a scale | Standard Deviation 57.34 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Pain (N= 49, 47) | -15.0 score on a scale | Standard Deviation 12.1 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Stiffness (N= 49, 46) | -4.0 score on a scale | Standard Deviation 6.34 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Physical Functioning (N= 42, 40) | -48.9 score on a scale | Standard Deviation 33.69 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Average (N= 42, 39) | -2.8 score on a scale | Standard Deviation 1.95 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Week 6: Total Score (N= 42, 39) | -66.5 score on a scale | Standard Deviation 46.9 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Pain (N= 46, 42) | -5.1 score on a scale | Standard Deviation 12.43 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Stiffness (N= 46, 42) | -0.1 score on a scale | Standard Deviation 4.9 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores | Change Day 3: Physical Functioning (N= 15, 16) | 17.0 score on a scale | Standard Deviation 39.37 |
Comparison: Change Day 3: Painp-value: 0.534two-sided Wilcoxon rank sum test
Comparison: Change Day 3: Stiffnessp-value: 0.269two-sided Wilcoxon rank sum test
Comparison: Change Day 3: Physical Functioningp-value: 0.693two-sided Wilcoxon rank sum test
Comparison: Change Day 3: Average Scorep-value: 0.343two-sided Wilcoxon rank sum test
Comparison: Change Day 3: Total Scorep-value: 0.343two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Painp-value: 0.978two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Stiffnessp-value: 0.709two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Physical Functioningp-value: 0.594two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Average Scorep-value: 0.501two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Total Scorep-value: 0.501two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Painp-value: 0.171two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Stiffnessp-value: 0.077two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Physical Functioningp-value: 0.026two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Average Scorep-value: 0.012two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Total Scorep-value: 0.012two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Painp-value: 0.126two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Stiffnessp-value: 0.044two-sided Wilcoxon rank sum test
p-value: 0.153two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Average Scorep-value: 0.134two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Total Scorep-value: 0.134two-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Time frame: Pre-operative and day 1 post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 1 | -9.0 percent | Standard Deviation 3.85 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 1 | -8.8 percent | Standard Deviation 3.92 |
p-value: 0.561one-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
Time frame: Pre-operative and day 2 post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 2 | -11.2 percent | Standard Deviation 4.67 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 2 | -10.6 percent | Standard Deviation 4.21 |
p-value: 0.356one-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
Time frame: Pre-operative and day 3 post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 3 | -11.1 percent | Standard Deviation 4.46 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Hematocrit (Hct) at Postoperative Day 3 | -11.0 percent | Standard Deviation 4.31 |
p-value: 0.533one-sided Wilcoxon rank sum test
Secondary
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores).
Time frame: Baseline and Postoperative Weeks 1, 2, and 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: PF (N= 39, 38) | 1.1 Scores on a scale | Standard Deviation 10.21 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: GH (N= 40, 40) | 0.1 Scores on a scale | Standard Deviation 6.23 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: RP (N= 36, 42) | -4.6 Scores on a scale | Standard Deviation 12.48 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: RE (N= 48, 47) | 5.9 Scores on a scale | Standard Deviation 17.2 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: BP (N= 40, 42) | 2.8 Scores on a scale | Standard Deviation 7.9 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: VT (N= 39, 40) | -5.9 Scores on a scale | Standard Deviation 9.66 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: GH (N= 39, 42) | -0.0 Scores on a scale | Standard Deviation 6.26 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: PF (N= 38, 37) | -2.1 Scores on a scale | Standard Deviation 10.18 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: VT (N= 39, 42) | -0.5 Scores on a scale | Standard Deviation 9.07 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: SF (N= 40, 40) | -10.8 Scores on a scale | Standard Deviation 12.75 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: SF (N= 40, 42) | -3.5 Scores on a scale | Standard Deviation 10.95 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: PCS (N= 45, 46) | 10.4 Scores on a scale | Standard Deviation 10.43 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: RE (N= 34, 41) | -0.7 Scores on a scale | Standard Deviation 16.89 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: RE (N= 36, 38) | -3.9 Scores on a scale | Standard Deviation 16.85 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: MH (N= 39, 42) | 0.8 Scores on a scale | Standard Deviation 12.36 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: RP (N= 38, 37) | -8.0 Scores on a scale | Standard Deviation 10.05 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: PCS (N= 32, 37) | -0.9 Scores on a scale | Standard Deviation 7.76 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: MH (N= 39, 40) | -2.3 Scores on a scale | Standard Deviation 10.79 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: MCS (N= 32, 37) | 0.3 Scores on a scale | Standard Deviation 12.9 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: MH (N= 48, 47) | 5.2 Scores on a scale | Standard Deviation 11.9 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: PF (N= 46, 46) | 12.0 Scores on a scale | Standard Deviation 11.34 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: PCS (N= 34, 37) | -3.8 Scores on a scale | Standard Deviation 8.97 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: RP (N= 49, 47) | 8.7 Scores on a scale | Standard Deviation 14.84 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: BP (N= 40, 40) | -2.3 Scores on a scale | Standard Deviation 10.93 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: BP (N= 49, 47) | 12.3 Scores on a scale | Standard Deviation 10.43 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: MCS (N= 34, 37) | -5.1 Scores on a scale | Standard Deviation 10.6 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: GH (N= 48, 47) | 1.9 Scores on a scale | Standard Deviation 6.33 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: MCS (N= 45, 46) | 2.1 Scores on a scale | Standard Deviation 12.53 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: VT (N= 48, 47) | 5.7 Scores on a scale | Standard Deviation 15 |
| Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: SF (N= 49, 47) | 5.8 Scores on a scale | Standard Deviation 14.62 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: VT (N= 48, 47) | 1.8 Scores on a scale | Standard Deviation 11.95 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: SF (N= 49, 47) | 2.4 Scores on a scale | Standard Deviation 13.64 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: RE (N= 48, 47) | 0.7 Scores on a scale | Standard Deviation 14.76 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: MH (N= 48, 47) | 2.1 Scores on a scale | Standard Deviation 14.52 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: PCS (N= 45, 46) | 7.8 Scores on a scale | Standard Deviation 8.62 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: MCS (N= 45, 46) | -0.2 Scores on a scale | Standard Deviation 13.97 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: PF (N= 38, 37) | -2.7 Scores on a scale | Standard Deviation 9.09 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: RP (N= 38, 37) | -6.6 Scores on a scale | Standard Deviation 11.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: BP (N= 40, 40) | -3.4 Scores on a scale | Standard Deviation 9.65 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: GH (N= 40, 40) | -1.1 Scores on a scale | Standard Deviation 7.68 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: VT (N= 39, 40) | -5.7 Scores on a scale | Standard Deviation 11.81 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: SF (N= 40, 40) | -6.7 Scores on a scale | Standard Deviation 15.3 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: RE (N= 36, 38) | -6.2 Scores on a scale | Standard Deviation 20.12 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: MH (N= 39, 40) | -0.4 Scores on a scale | Standard Deviation 11.26 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: PCS (N= 34, 37) | -3.5 Scores on a scale | Standard Deviation 7.73 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 1: MCS (N= 34, 37) | -4.1 Scores on a scale | Standard Deviation 14.13 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: PF (N= 39, 38) | -1.2 Scores on a scale | Standard Deviation 7.07 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: RP (N= 36, 42) | -6.9 Scores on a scale | Standard Deviation 9.08 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: BP (N= 40, 42) | -1.4 Scores on a scale | Standard Deviation 9.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: GH (N= 39, 42) | 1.0 Scores on a scale | Standard Deviation 8.92 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: VT (N= 39, 42) | -2.1 Scores on a scale | Standard Deviation 12.39 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: SF (N= 40, 42) | -6.4 Scores on a scale | Standard Deviation 13.14 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: RE (N= 34, 41) | -6.6 Scores on a scale | Standard Deviation 16.08 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: MH (N= 39, 42) | 0.5 Scores on a scale | Standard Deviation 12.83 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: PCS (N= 32, 37) | -2.4 Scores on a scale | Standard Deviation 6.89 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 2: MCS (N= 32, 37) | -2.0 Scores on a scale | Standard Deviation 12.83 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: PF (N= 46, 46) | 8.0 Scores on a scale | Standard Deviation 7.89 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: RP (N= 49, 47) | 5.4 Scores on a scale | Standard Deviation 12.2 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: BP (N= 49, 47) | 7.7 Scores on a scale | Standard Deviation 10 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 | Change Week 6: GH (N= 48, 47) | 2.5 Scores on a scale | Standard Deviation 9.73 |
Comparison: Change Week 1: Physical Functioningp-value: 0.962two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Role-Physicalp-value: 0.714two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Bodily Painp-value: 0.668two-sided Wilcoxon rank sum test
Comparison: Change Week 1: General Healthp-value: 0.556two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Vitalityp-value: 0.705two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Social Functioningp-value: 0.122two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Role-Emotionalp-value: 0.254two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Mental Healthp-value: 0.5two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Physical Component Summaryp-value: 0.849two-sided Wilcoxon rank sum test
Comparison: Change Week 1: Mental Component Summaryp-value: 0.959Wilcoxon (Mann-Whitney)
Comparison: Change Week 2: Physical Functioningp-value: 0.574two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Role-Physicalp-value: 0.524two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Bodily Painp-value: 0.049two-sided Wilcoxon rank sum test
Comparison: Change Week 2: General Healthp-value: 0.447two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Vitalityp-value: 0.823two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Social Functioningp-value: 0.661two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Role-Emotionalp-value: 0.086two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Mental Healthp-value: 0.635two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Physical Component Summaryp-value: 0.481two-sided Wilcoxon rank sum test
Comparison: Change Week 2: Mental Component Summaryp-value: 0.14two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Physical Functioningp-value: 0.107two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Role-Physicalp-value: 0.298two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Bodily Painp-value: 0.071two-sided Wilcoxon rank sum test
Comparison: Change Week 6: General Healthp-value: 0.94two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Vitalityp-value: 0.293two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Social Functioningp-value: 0.265two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Role-Emotionalp-value: 0.036two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Mental Healthp-value: 0.307two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Physical Component Summaryp-value: 0.448two-sided Wilcoxon rank sum test
Comparison: Change Week 6: Mental Component Summaryp-value: 0.255two-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3 | -1.6 score on a scale | Standard Deviation 3.18 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3 | -0.1 score on a scale | Standard Deviation 3.54 |
p-value: 0.058two-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1 | -0.4 score on a scale | Standard Deviation 2.88 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1 | 0.4 score on a scale | Standard Deviation 2.97 |
p-value: 0.421two-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2 | -1.8 score on a scale | Standard Deviation 2.64 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2 | -0.5 score on a scale | Standard Deviation 3.18 |
p-value: 0.161two-sided Wilcoxon rank sum test
Secondary
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6 | -3.5 score on a scale | Standard Deviation 2.65 |
| FLOSEAL + Standard of Care (SoC) | Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6 | -2.1 score on a scale | Standard Deviation 2.52 |
p-value: 0.016two-sided Wilcoxon rank sum test
Secondary
Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
Time frame: Pre-operative and day 1 post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively | -3.02 g/dL | Standard Deviation 1.069 |
| FLOSEAL + Standard of Care (SoC) | Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively | -3.15 g/dL | Standard Deviation 1.217 |
p-value: 0.708one-sided, two-sample t-test
Secondary
Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
Time frame: Pre-operative and day 3 post-operatively
Population: Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively | -3.81 g/dL | Standard Deviation 1.427 |
| FLOSEAL + Standard of Care (SoC) | Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively | -3.84 g/dL | Standard Deviation 1.324 |
p-value: 0.527one-sided, two-sample t-test
Secondary
Duration of Surgery
Time frame: Time from first incision to complete wound closure (Day 0)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Duration of Surgery | 74.5 minutes | Standard Deviation 19.73 |
| FLOSEAL + Standard of Care (SoC) | Duration of Surgery | 76.9 minutes | Standard Deviation 17.33 |
Secondary
Length of Hospital Stay
Time frame: From the day of hospitalization to the day of discharge
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Length of Hospital Stay | 3.52 Days | Standard Deviation 0.857 |
| FLOSEAL + Standard of Care (SoC) | Length of Hospital Stay | 3.38 Days | Standard Deviation 0.918 |
p-value: 0.052two-sided Wilcoxon rank sum test
Secondary
Pain Management - Number of Days When Pain Medication Was Used
Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis. While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary.
Time frame: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Pain Management - Number of Days When Pain Medication Was Used | All pain medications | 28.7 days | Standard Deviation 13.71 |
| Standard of Care (SoC) | Pain Management - Number of Days When Pain Medication Was Used | Narcotics | 25.1 days | Standard Deviation 13.66 |
| FLOSEAL + Standard of Care (SoC) | Pain Management - Number of Days When Pain Medication Was Used | All pain medications | 31.9 days | Standard Deviation 12.72 |
| FLOSEAL + Standard of Care (SoC) | Pain Management - Number of Days When Pain Medication Was Used | Narcotics | 30.3 days | Standard Deviation 12.84 |
Secondary
Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
Time frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Population: Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery | 0.26 Proportion of participants |
| FLOSEAL + Standard of Care (SoC) | Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery | 0.36 Proportion of participants |
Secondary
Proportion of Participants With Transfusion Requirements
Time frame: Intra-operative
Population: Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants With Transfusion Requirements | 0.25 Proportion of participants |
| FLOSEAL + Standard of Care (SoC) | Proportion of Participants With Transfusion Requirements | 0.19 Proportion of participants |
Secondary
Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
Time frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
Population: Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage) | 0.03 Proportion of participants |
| FLOSEAL + Standard of Care (SoC) | Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage) | 0.06 Proportion of participants |
Secondary
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.
Time frame: Preoperative, and Postoperative Weeks 1, 2, and 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: PF (N= 39, 37) | 23.1 Scores on a scale | Standard Deviation 7.88 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline RP (N= 50, 47) | 32.9 Scores on a scale | Standard Deviation 10.87 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline BP (N= 50, 47) | 35.5 Scores on a scale | Standard Deviation 7.58 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline GH (N= 49, 47) | 52.3 Scores on a scale | Standard Deviation 6.34 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline VT (N= 49, 47) | 47.9 Scores on a scale | Standard Deviation 10.73 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline SF (N= 50, 47) | 42.1 Scores on a scale | Standard Deviation 11.73 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline RE (N= 49, 47) | 40.7 Scores on a scale | Standard Deviation 14.11 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline MH (N= 49, 47) | 48.9 Scores on a scale | Standard Deviation 10.25 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline PCS (N= 48, 47) | 31.4 Scores on a scale | Standard Deviation 7.11 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline MCS (N= 48, 47) | 52.3 Scores on a scale | Standard Deviation 12.46 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline PF (N= 49, 47) | 24.9 Scores on a scale | Standard Deviation 6.37 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: RP (N= 38, 37) | 25.3 Scores on a scale | Standard Deviation 8.02 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: BP (N= 40, 40) | 33.9 Scores on a scale | Standard Deviation 7.99 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: GH (N= 41, 40) | 52.9 Scores on a scale | Standard Deviation 5.43 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: VT (N= 40, 40) | 43.3 Scores on a scale | Standard Deviation 11.02 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: SF (N= 40, 40) | 33.0 Scores on a scale | Standard Deviation 12.7 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: RE (N= 37, 38) | 36.8 Scores on a scale | Standard Deviation 17.03 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: MH (N= 40, 40) | 48.0 Scores on a scale | Standard Deviation 10.35 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: PCS (N= 36, 37) | 28.4 Scores on a scale | Standard Deviation 7.26 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: MCS (N= 36, 37) | 47.9 Scores on a scale | Standard Deviation 12.38 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: PF (N= 40, 38) | 26.0 Scores on a scale | Standard Deviation 8.4 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: RP (N= 36, 42) | 28.1 Scores on a scale | Standard Deviation 9.47 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: BP (N= 40, 42) | 38.8 Scores on a scale | Standard Deviation 7.34 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: GH (N= 40, 42) | 52.4 Scores on a scale | Standard Deviation 6.91 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: VT (N= 40, 42) | 47.6 Scores on a scale | Standard Deviation 6.55 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: SF (N= 40, 42) | 39.4 Scores on a scale | Standard Deviation 9.5 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: RE (N= 35, 41) | 38.9 Scores on a scale | Standard Deviation 15.81 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: MH (N= 40, 42) | 50.7 Scores on a scale | Standard Deviation 10.18 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: PCS (N= 33, 37) | 30.5 Scores on a scale | Standard Deviation 7.72 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: MCS (N= 33, 37) | 51.7 Scores on a scale | Standard Deviation 13 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: PF (N= 47, 46) | 37.0 Scores on a scale | Standard Deviation 11.13 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: RP (N= 49, 47) | 41.8 Scores on a scale | Standard Deviation 11.05 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: BP (N= 49, 47) | 47.7 Scores on a scale | Standard Deviation 9.2 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: GH (N= 49, 47) | 54.2 Scores on a scale | Standard Deviation 6.41 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: VT (N= 49, 47) | 53.4 Scores on a scale | Standard Deviation 10.31 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: SF (N= 49, 47) | 48.2 Scores on a scale | Standard Deviation 10.5 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: RE (N= 49, 47) | 46.5 Scores on a scale | Standard Deviation 12.52 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: MH (N= 49, 47) | 54.0 Scores on a scale | Standard Deviation 8.96 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: PCS (N= 47, 46) | 41.7 Scores on a scale | Standard Deviation 8.87 |
| Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: MCS (N= 47, 46) | 54.5 Scores on a scale | Standard Deviation 8.96 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: MH (N= 49, 47) | 52.3 Scores on a scale | Standard Deviation 11.24 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline PF (N= 49, 47) | 25.8 Scores on a scale | Standard Deviation 7.81 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: PF (N= 40, 38) | 24.3 Scores on a scale | Standard Deviation 7.06 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline RP (N= 50, 47) | 33.5 Scores on a scale | Standard Deviation 11.06 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: PF (N= 47, 46) | 34.0 Scores on a scale | Standard Deviation 9.75 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline BP (N= 50, 47) | 36.2 Scores on a scale | Standard Deviation 9.21 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: RP (N= 36, 42) | 26.7 Scores on a scale | Standard Deviation 7.35 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline GH (N= 49, 47) | 50.2 Scores on a scale | Standard Deviation 9.83 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: SF (N= 49, 47) | 47.3 Scores on a scale | Standard Deviation 10.94 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline VT (N= 49, 47) | 47.3 Scores on a scale | Standard Deviation 9.98 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: BP (N= 40, 42) | 35.1 Scores on a scale | Standard Deviation 6.01 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline SF (N= 50, 47) | 44.9 Scores on a scale | Standard Deviation 12.18 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: RP (N= 49, 47) | 38.8 Scores on a scale | Standard Deviation 11.03 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline RE (N= 49, 47) | 45.8 Scores on a scale | Standard Deviation 14.29 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: GH (N= 40, 42) | 51.9 Scores on a scale | Standard Deviation 9.59 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline MH (N= 49, 47) | 50.2 Scores on a scale | Standard Deviation 10.32 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: MCS (N= 47, 46) | 55.1 Scores on a scale | Standard Deviation 11.32 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline PCS (N= 48, 47) | 30.3 Scores on a scale | Standard Deviation 8.41 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: VT (N= 40, 42) | 45.8 Scores on a scale | Standard Deviation 10.6 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Baseline MCS (N= 48, 47) | 55.2 Scores on a scale | Standard Deviation 12.28 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: BP (N= 49, 47) | 43.9 Scores on a scale | Standard Deviation 8.43 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: PF (N= 39, 37) | 22.9 Scores on a scale | Standard Deviation 8.16 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: SF (N= 40, 42) | 37.6 Scores on a scale | Standard Deviation 12.82 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: RP (N= 38, 37) | 26.5 Scores on a scale | Standard Deviation 9.99 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: RE (N= 49, 47) | 46.5 Scores on a scale | Standard Deviation 12.57 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: BP (N= 40, 40) | 33.1 Scores on a scale | Standard Deviation 8.09 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: RE (N= 35, 41) | 40.2 Scores on a scale | Standard Deviation 15.97 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: GH (N= 41, 40) | 50.1 Scores on a scale | Standard Deviation 10.09 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: GH (N= 49, 47) | 52.7 Scores on a scale | Standard Deviation 9.44 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: VT (N= 40, 40) | 42.0 Scores on a scale | Standard Deviation 10.64 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: MH (N= 40, 42) | 51.5 Scores on a scale | Standard Deviation 10.32 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: SF (N= 40, 40) | 37.1 Scores on a scale | Standard Deviation 14.12 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: PCS (N= 33, 37) | 27.8 Scores on a scale | Standard Deviation 7.33 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: RE (N= 37, 38) | 39.5 Scores on a scale | Standard Deviation 17.97 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: PCS (N= 47, 46) | 38.1 Scores on a scale | Standard Deviation 9.29 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: MH (N= 40, 40) | 50.0 Scores on a scale | Standard Deviation 9.96 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 6: VT (N= 49, 47) | 49.1 Scores on a scale | Standard Deviation 9.63 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: PCS (N= 36, 37) | 26.6 Scores on a scale | Standard Deviation 7.16 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 2: MCS (N= 33, 37) | 53.2 Scores on a scale | Standard Deviation 10.89 |
| FLOSEAL + Standard of Care (SoC) | Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 | Change Week 1: MCS (N= 36, 37) | 51.1 Scores on a scale | Standard Deviation 13.18 |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 31 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 9 (N= 37, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 32 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 17 (N= 38, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 33 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 2 (N= 47, 50) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 34 (N= 37, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 18 (N= 40, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 35 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 10 (N= 34, 40) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 36 (N= 38, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 19 (N= 41, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 37 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 6 (N= 42, 42) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 38 (N= 36, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 20 (N= 40, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 39 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 11 (N= 36, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 40 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 21 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 41 (N= 32, 36) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 4 (N= 46, 48) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 42 (N= 31, 35) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 22 (N= 39, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 43 (N= 25, 31) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 12 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 44 (N= 6, 8) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 23 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 45 (N= 3, 4) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 7 (N= 40, 42) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 46 (N= 3, 2) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 24 (N= 40, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 13 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 25 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 3 (N= 46, 50) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 26 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 14 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 27 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 53 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 8 (N= 38, 42) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 28 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 15 (N= 40, 42) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 29 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 5 (N= 42, 44) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 30 (N= 36, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 16 (N= 40, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 1 (N= 47, 50) | 23 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 1 (N= 47, 50) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 2 (N= 47, 50) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 3 (N= 46, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 4 (N= 46, 48) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 5 (N= 42, 44) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 6 (N= 42, 42) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 7 (N= 40, 42) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 8 (N= 38, 42) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 9 (N= 37, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 10 (N= 34, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 11 (N= 36, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 12 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 13 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 14 (N= 39, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 15 (N= 40, 42) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 16 (N= 40, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 17 (N= 38, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 18 (N= 40, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 19 (N= 41, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 20 (N= 40, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 21 (N= 39, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 22 (N= 39, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 23 (N= 39, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 24 (N= 40, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 25 (N= 39, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 26 (N= 39, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 27 (N= 39, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 28 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 29 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 30 (N= 36, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 31 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 32 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 33 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 34 (N= 37, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 35 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 36 (N= 38, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 37 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 38 (N= 36, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 39 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 40 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 41 (N= 32, 36) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 42 (N= 31, 35) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 43 (N= 25, 31) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 44 (N= 6, 8) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed | Day 59 (N= 0, 1) | 0 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 31 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 9 (N= 37, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 32 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 17 (N= 38, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 33 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 2 (N= 47, 50) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 34 (N= 37, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 18 (N= 40, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 35 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 10 (N= 34, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 36 (N= 38, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 19 (N= 41,41 ) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 37 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 6 (N= 40, 42) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 38 (N= 36, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 20 (N= 40, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 39 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 11 (N= 36, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 40 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 21 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 41 (N= 32, 36) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 4 (N= 46, 48) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 42 (N= 31, 35) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 22 (N= 39, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 43 (N= 25, 31) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 12 (N= 36, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 44 (N= 6, 8) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 23 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 45 (N= 3, 4) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 7 (N= 40, 42) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 46 (N= 3, 2) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 24 (N= 40, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 13 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 25 (N= 39, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 3 (N= 46, 50) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 26 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 14 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 27 (N= 39, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 53 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 8 (N= 38, 42) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 28 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 15 (N= 40, 42) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 29 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 5 (N= 42, 44) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 30 (N= 36, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 16 (N= 40, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 1 (N= 47, 50) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 1 (N= 47, 50) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 2 (N= 47, 50) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 3 (N= 46, 50) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 4 (N= 46, 48) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 5 (N= 42, 44) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 6 (N= 40, 42) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 7 (N= 40, 42) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 8 (N= 38, 42) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 9 (N= 37, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 10 (N= 34, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 11 (N= 36, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 12 (N= 36, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 13 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 14 (N= 39, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 15 (N= 40, 42) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 16 (N= 40, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 17 (N= 38, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 18 (N= 40, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 19 (N= 41,41 ) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 20 (N= 40, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 21 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 22 (N= 39, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 23 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 24 (N= 40, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 25 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 26 (N= 39, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 27 (N= 39, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 28 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 29 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 30 (N= 36, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 31 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 32 (N= 37, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 33 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 34 (N= 37, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 35 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 36 (N= 38, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 37 (N= 36, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 38 (N= 36, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 39 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 40 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 41 (N= 32, 36) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 42 (N= 31, 35) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 43 (N= 25, 31) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 44 (N= 6, 8) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk | Day 59 (N= 0, 1) | 0 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 31 (N= 35, 40) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 8 (N= 37, 42) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 32 (N= 37, 40) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 16 (N= 39, 41) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 33 (N= 37, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 1 (N= 45, 48) | 24 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 34 (N= 37, 39) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 17 (N= 37, 41) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 35 (N= 38, 39) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 9 (N= 35, 39) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 36 (N= 38, 39) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 18 (N= 38, 41) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 37 (N= 35, 38) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 5 (N= 39, 42) | 27 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 38 (N= 35, 41) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 19 (N= 40, 40) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 39 (N= 36, 39) | 11 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 10 (N= 32, 38) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 40 (N= 37, 40) | 11 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 20 (N= 38, 40) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 41 (N= 32, 36) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 3 (N= 44, 49) | 43 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 42 (N= 30, 35) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 21 (N= 38, 40) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 43 (N= 25, 31) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 22 (N= 38, 41) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 44 (N= 6, 7) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 11 (N= 35, 41) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 45 (N= 3, 4) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 23 (N= 38, 39) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 46 (N= 3, 2) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 6 (N= 35, 39) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 24 (N= 39, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 12 (N= 34, 37) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 25 (N= 37, 40) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 2 (N= 45, 49) | 42 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 26 (N= 38, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 13 (N= 36, 38) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 53 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 27 (N= 38, 38) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 7 (N= 37, 39) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 28 (N= 37, 39) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 14 (N= 39, 36) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 29 (N= 38, 39) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 4 (N= 45, 47) | 41 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 30 (N= 36, 40) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 15 (N= 39, 41) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 1 (N= 45, 48) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 2 (N= 45, 49) | 47 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 3 (N= 44, 49) | 48 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 4 (N= 45, 47) | 46 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 5 (N= 39, 42) | 31 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 6 (N= 35, 39) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 7 (N= 37, 39) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 8 (N= 37, 42) | 24 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 9 (N= 35, 39) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 10 (N= 32, 38) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 11 (N= 35, 41) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 12 (N= 34, 37) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 13 (N= 36, 38) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 14 (N= 39, 36) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 15 (N= 39, 41) | 24 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 16 (N= 39, 41) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 17 (N= 37, 41) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 18 (N= 38, 41) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 19 (N= 40, 40) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 20 (N= 38, 40) | 9 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 22 (N= 38, 41) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 23 (N= 38, 39) | 10 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 24 (N= 39, 39) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 25 (N= 37, 40) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 26 (N= 38, 39) | 9 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 27 (N= 38, 38) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 28 (N= 37, 39) | 8 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 29 (N= 38, 39) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 30 (N= 36, 40) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 31 (N= 35, 40) | 10 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 32 (N= 37, 40) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 33 (N= 37, 39) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 34 (N= 37, 39) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 35 (N= 38, 39) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 36 (N= 38, 39) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 37 (N= 35, 38) | 10 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 38 (N= 35, 41) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 39 (N= 36, 39) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 40 (N= 37, 40) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 41 (N= 32, 36) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 42 (N= 30, 35) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 43 (N= 25, 31) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 44 (N= 6, 7) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 45 (N= 3, 4) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 46 (N= 3, 2) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 59 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist | Day 21 (N= 38, 40) | 10 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 31 (N= 37, 40) | 21 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 9 (N= 37, 41) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 32 (N= 37, 40) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 17 (N= 38, 41) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 33 (N= 38, 39) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 2 (N= 47, 50) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 34 (N= 37, 39) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 18 (N= 40, 41) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 35 (N= 38, 39) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 10 (N= 34, 40) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 36 (N= 38, 40) | 22 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 19 (N= 41, 41) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 37 (N= 36, 39) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 6 (N= 40, 42) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 38 (N= 36, 41) | 24 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 20 (N= 40, 40) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 39 (N= 36, 39) | 24 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 11 (N= 36, 41) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 40 (N= 37, 40) | 25 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 21 (N= 39, 40) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 41 (N= 32, 36) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 4 (N= 46, 48) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 42 (N= 31, 35) | 22 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 22 (N= 39, 41) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 43 (N= 25, 31) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 12 (N= 36, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 44 (N= 6, 8) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 23 (N= 39, 40) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 45 (N= 3, 4) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 7 (N= 40, 42) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 46 (N= 3, 2) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 24 (N= 40, 39) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 13 (N= 38, 39) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 25 (N= 39, 40) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 3 (N= 46, 50) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 26 (N= 39, 39) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 14 (N= 39, 39) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 27 (N= 39, 39) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 53(N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 8 (N= 38, 42) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 28 (N= 38, 39) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 15 (N= 40, 42) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 29 (N= 38, 39) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 5 (N= 42, 44) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 30 (N= 36, 40) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 16 (N= 40, 41) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 1 (N= 47, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 60 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 1 (N= 47, 50) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 2 (N= 47, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 3 (N= 46, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 4 (N= 46, 48) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 5 (N= 42, 44) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 6 (N= 40, 42) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 7 (N= 40, 42) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 8 (N= 38, 42) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 9 (N= 37, 41) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 10 (N= 34, 40) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 11 (N= 36, 41) | 8 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 12 (N= 36, 39) | 10 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 13 (N= 38, 39) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 14 (N= 39, 39) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 15 (N= 40, 42) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 16 (N= 40, 41) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 17 (N= 38, 41) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 18 (N= 40, 41) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 19 (N= 41, 41) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 20 (N= 40, 40) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 21 (N= 39, 40) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 22 (N= 39, 41) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 23 (N= 39, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 24 (N= 40, 39) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 25 (N= 39, 40) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 26 (N= 39, 39) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 27 (N= 39, 39) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 28 (N= 38, 39) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 29 (N= 38, 39) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 30 (N= 36, 40) | 26 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 31 (N= 37, 40) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 32 (N= 37, 40) | 25 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 33 (N= 38, 39) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 34 (N= 37, 39) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 35 (N= 38, 39) | 28 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 36 (N= 38, 40) | 29 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 37 (N= 36, 39) | 28 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 38 (N= 36, 41) | 30 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 39 (N= 36, 39) | 29 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 40 (N= 37, 40) | 30 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 41 (N= 32, 36) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 42 (N= 31, 35) | 26 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 43 (N= 25, 31) | 24 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 44 (N= 6, 8) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 45 (N= 3, 4) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 46 (N= 3, 2) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 47 (N= 1, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 48 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 49 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 50 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 51 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 52 (N= 1, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 53(N= 1, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 54 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 55 (N= 1, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 56 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 57 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 58 (N= 0, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance | Day 59 (N= 0, 1) | 1 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 31 (N= 37, 40) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 9 (N= 37, 41) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 32 (N= 37, 40) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 17 (N= 38, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 33 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 2 (N= 47, 50) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 34 (N= 37, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 18 (N= 40, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 35 (N= 38, 39) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 10 (N= 34, 40) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 36 (N= 38, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 19 (N= 41, 41) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 37 (N= 36, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 6 (N= 40, 42) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 38 (N= 36, 41) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 20 (N= 40, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 39 (N= 36, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 11 (N= 36, 41) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 40 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 21 (N= 39, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 41 (N= 32, 36) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 4 (N= 46, 48) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 42 (N= 31, 35) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 22 (N= 39, 41) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 43 (N= 25, 31) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 12 (N= 36, 39) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 44 (N= 6, 8) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 23 (N= 39, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 45 (N= 3, 4) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 7 (N= 40, 42) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 46 (N= 3, 2) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 24 (N= 40, 39) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 13 (N= 38, 39) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 25 (N= 39, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 3 (N= 46, 50) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 26 (N= 39, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 14 (N= 39, 39) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 27 (N= 39, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 53 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 8 (N= 38, 42) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 28 (N= 38, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 15 (N= 40, 42) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 29 (N= 38, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 5 (N= 42, 44) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 30 (N= 36, 40) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 16 (N= 40, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 1 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 1 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 2 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 3 (N= 46, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 4 (N= 46, 48) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 5 (N= 42, 44) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 6 (N= 40, 42) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 7 (N= 40, 42) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 8 (N= 38, 42) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 9 (N= 37, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 10 (N= 34, 40) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 11 (N= 36, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 12 (N= 36, 39) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 13 (N= 38, 39) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 14 (N= 39, 39) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 15 (N= 40, 42) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 16 (N= 40, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 17 (N= 38, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 18 (N= 40, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 19 (N= 41, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 20 (N= 40, 40) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 21 (N= 39, 40) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 22 (N= 39, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 23 (N= 39, 40) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 24 (N= 40, 39) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 25 (N= 39, 40) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 26 (N= 39, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 27 (N= 39, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 28 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 29 (N= 38, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 30 (N= 36, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 31 (N= 37, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 32 (N= 37, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 33 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 34 (N= 37, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 35 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 36 (N= 38, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 37 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 38 (N= 36, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 39 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 40 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 41 (N= 32, 36) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 42 (N= 31, 35) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 43 (N= 25, 31) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 44 (N= 6, 8) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) | Day 59 (N= 0, 1) | 0 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 31 (N= 37, 40) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 9 (N= 37, 41) | 26 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 32 (N= 37, 40) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 17 (N= 38, 41) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 33 (N= 38, 39) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 2 (N= 47, 50) | 39 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 34 (N= 37, 39) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 18 (N= 40, 41) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 35 (N= 38, 39) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 10 (N= 34, 40) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 36 (N= 38, 40) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 19 (N= 41,41 ) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 37 (N= 36, 39) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 6 (N= 40, 42) | 34 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 38 (N= 36, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 20 (N= 40, 40) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 39 (N= 36, 39) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 11 (N= 36, 41) | 24 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 40 (N= 37, 40) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 21 (N= 39, 40) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 41 (N= 32, 36) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 4 (N= 46, 48) | 38 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 42 (N= 31, 35) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 22 (N= 39, 41) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 43 (N= 25, 31) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 12 (N= 36, 39) | 24 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 44 (N= 6, 8) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 23 (N= 39, 40) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 45 (N= 3, 4) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 7 (N= 40, 42) | 32 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 46 (N= 3, 2) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 24 (N= 40, 39) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 13 (N= 38, 39) | 26 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 25 (N= 39, 40) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 49(N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 3 (N= 46, 50) | 38 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 26 (N= 39, 39) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 14 (N= 39, 39) | 23 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 52 (N= 1, 1) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 27 (N= 39, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 53 (N= 1, 1) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 8 (N= 38, 42) | 31 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 28 (N= 38, 39) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 55 (N= 1, 1) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 15 (N= 40, 42) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 29 (N= 38, 39) | 8 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 5 (N= 42, 44) | 33 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 30 (N= 36, 40) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 16 (N= 40, 41) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 1 (N= 47, 50) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 1 (N= 47, 50) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 2 (N= 47, 50) | 41 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 3 (N= 46, 50) | 46 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 4 (N= 46, 48) | 44 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 5 (N= 42, 44) | 40 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 6 (N= 40, 42) | 38 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 7 (N= 40, 42) | 38 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 8 (N= 38, 42) | 36 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 9 (N= 37, 41) | 34 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 10 (N= 34, 40) | 33 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 11 (N= 36, 41) | 32 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 12 (N= 36, 39) | 27 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 13 (N= 38, 39) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 14 (N= 39, 39) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 15 (N= 40, 42) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 16 (N= 40, 41) | 23 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 17 (N= 38, 41) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 18 (N= 40, 41) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 19 (N= 41,41 ) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 20 (N= 40, 40) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 21 (N= 39, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 22 (N= 39, 41) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 23 (N= 39, 40) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 24 (N= 40, 39) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 25 (N= 39, 40) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 26 (N= 39, 39) | 9 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 27 (N= 39, 39) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 28 (N= 38, 39) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 29 (N= 38, 39) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 30 (N= 36, 40) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 31 (N= 37, 40) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 32 (N= 37, 40) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 33 (N= 38, 39) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 34 (N= 37, 39) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 35 (N= 38, 39) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 36 (N= 38, 40) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 37 (N= 36, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 38 (N= 36, 41) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 39 (N= 36, 39) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 40 (N= 37, 40) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 41 (N= 32, 36) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 42 (N= 31, 35) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 43 (N= 25, 31) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 44 (N= 6, 8) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 49(N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker | Day 59 (N= 0, 1) | 0 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 31 (N= 37, 40) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 9 (N= 37, 41) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 32 (N= 37, 40) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 17 (N= 38, 41) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 33 (N= 38, 39) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 2 (N= 47, 50) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 34 (N= 37, 39) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 18 (N= 40, 41) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 35 (N= 38, 39) | 14 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 10 (N= 34, 40) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 36 (N= 38, 40) | 15 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 19 (N= 41, 41) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 37 (N= 36, 39) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 6 (N= 40, 42) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 38 (N= 36, 41) | 10 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 20 (N= 40, 40) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 39 (N= 36, 39) | 13 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 11 (N= 36, 41) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 40 (N= 37, 40) | 11 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 21 (N= 39, 40) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 41 (N= 32, 36) | 9 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 4 (N= 46, 48) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 42 (N= 31, 35) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 22 (N= 39, 41) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 43 (N= 25, 31) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 12 (N= 36, 39) | 11 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 44 (N= 6, 8) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 23 (N= 39, 40) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 45 (N= 3, 4) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 7 (N= 40, 42) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 46 (N= 3, 2) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 24 (N= 40, 39) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 47 (N= 1, 1) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 13 (N= 38, 39) | 12 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 25 (N= 39, 40) | 19 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 3 (N= 46, 50) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 26 (N= 39, 39) | 21 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 14 (N= 39, 39) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 27 (N= 39, 39) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 53 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 8 (N= 38, 42) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 28 (N= 38, 39) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 55 (N= 1, 1) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 15 (N= 40, 42) | 18 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 29 (N= 38, 39) | 17 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 5 (N= 42, 44) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 30 (N= 36, 40) | 16 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 16 (N= 40, 41) | 20 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 1 (N= 47, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 1 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 2 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 3 (N= 46, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 4 (N= 46, 48) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 5 (N= 42, 44) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 6 (N= 40, 42) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 7 (N= 40, 42) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 8 (N= 38, 42) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 9 (N= 37, 41) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 10 (N= 34, 40) | 6 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 11 (N= 36, 41) | 7 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 12 (N= 36, 39) | 10 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 13 (N= 38, 39) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 14 (N= 39, 39) | 12 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 15 (N= 40, 42) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 16 (N= 40, 41) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 17 (N= 38, 41) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 18 (N= 40, 41) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 19 (N= 41, 41) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 20 (N= 40, 40) | 22 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 21 (N= 39, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 22 (N= 39, 41) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 23 (N= 39, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 24 (N= 40, 39) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 25 (N= 39, 40) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 26 (N= 39, 39) | 21 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 27 (N= 39, 39) | 20 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 28 (N= 38, 39) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 29 (N= 38, 39) | 19 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 30 (N= 36, 40) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 31 (N= 37, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 32 (N= 37, 40) | 18 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 33 (N= 38, 39) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 34 (N= 37, 39) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 35 (N= 38, 39) | 13 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 36 (N= 38, 40) | 17 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 37 (N= 36, 39) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 38 (N= 36, 41) | 16 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 39 (N= 36, 39) | 14 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 40 (N= 37, 40) | 15 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 41 (N= 32, 36) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 42 (N= 31, 35) | 11 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 43 (N= 25, 31) | 9 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 44 (N= 6, 8) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 47 (N= 1, 1) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 53 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane | Day 59 (N= 0, 1) | 0 participants |
Secondary
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
The number of participants responding affirmative in their rehabilitation diaries for each day
Time frame: 60 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 31 (N= 37, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 9 (N= 37, 41) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 32 (N= 37, 40) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 17 (N= 38, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 33 (N= 38, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 2 (N= 47, 50) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 34 (N= 37, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 18 (N= 40, 41) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 35 (N= 38, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 10 (N= 34, 40) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 36 (N= 38, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 19 (N= 41, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 37 (N= 36, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 6 (N= 40, 42) | 5 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 38 (N= 36, 41) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 20 (N= 40, 40) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 39 (N= 36, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 11 (N= 36, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 40 (N= 37, 40) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 21 (N= 39, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 41 (N= 32, 36) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 4 (N= 46, 48) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 42 (N= 31, 35) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 22 (N= 39, 41) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 43 (N= 25, 31) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 12 (N= 36, 39) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 44 (N= 6,8 ) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 23 (N= 39, 40) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 45 (N= 3, 4) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 7 (N= 40, 42) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 46 (N= 3, 2) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 24 (N= 40, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 47 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 13 (N= 38, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 48 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 25 (N= 39, 40) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 49 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 3 (N= 46, 50) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 50 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 26 (N= 39, 39) | 1 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 51 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 14 (N= 39, 39) | 3 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 52 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 27 (N= 39, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 53(N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 8 (N= 38, 42) | 6 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 54 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 28 (N= 38, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 55 (N= 1, 1) | 0 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 15 (N= 40, 42) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 56 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 29 (N= 38, 39) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 57 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 5 (N= 42, 44) | 7 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 58 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 30 (N= 36, 40) | 2 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 59 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 16 (N= 40, 41) | 4 participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 60 (N= 0, 1) | NA participants |
| Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 1 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 60 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 1 (N= 47, 50) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 2 (N= 47, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 3 (N= 46, 50) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 4 (N= 46, 48) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 5 (N= 42, 44) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 6 (N= 40, 42) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 7 (N= 40, 42) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 8 (N= 38, 42) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 9 (N= 37, 41) | 4 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 10 (N= 34, 40) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 11 (N= 36, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 12 (N= 36, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 13 (N= 38, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 14 (N= 39, 39) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 15 (N= 40, 42) | 5 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 16 (N= 40, 41) | 3 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 17 (N= 38, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 18 (N= 40, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 19 (N= 41, 41) | 2 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 20 (N= 40, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 21 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 22 (N= 39, 41) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 23 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 24 (N= 40, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 25 (N= 39, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 26 (N= 39, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 27 (N= 39, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 28 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 29 (N= 38, 39) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 30 (N= 36, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 31 (N= 37, 40) | 1 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 32 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 33 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 34 (N= 37, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 35 (N= 38, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 36 (N= 38, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 37 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 38 (N= 36, 41) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 39 (N= 36, 39) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 40 (N= 37, 40) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 41 (N= 32, 36) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 42 (N= 31, 35) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 43 (N= 25, 31) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 44 (N= 6,8 ) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 45 (N= 3, 4) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 46 (N= 3, 2) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 47 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 48 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 49 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 50 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 51 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 52 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 53(N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 54 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 55 (N= 1, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 56 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 57 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 58 (N= 0, 1) | 0 participants |
| FLOSEAL + Standard of Care (SoC) | Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair | Day 59 (N= 0, 1) | 0 participants |
Secondary
Total Drain Output at Day 1 Post-operatively
Time frame: 1 day post-operatively
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Total Drain Output at Day 1 Post-operatively | 839.6 mL | Standard Deviation 476.38 |
| FLOSEAL + Standard of Care (SoC) | Total Drain Output at Day 1 Post-operatively | 647.3 mL | Standard Deviation 338.96 |
p-value: 0.063two-sided Wilcoxon rank sum test
Secondary
Total Tourniquet Time
Measured from the time point of the tourniquet inflation to deflation using the same watch/clock
Time frame: Intra-operatively (on day of surgery = Day 0)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Total Tourniquet Time | 49.2 minutes | Standard Deviation 19.76 |
| FLOSEAL + Standard of Care (SoC) | Total Tourniquet Time | 47.3 minutes | Standard Deviation 17.45 |
p-value: 0.734two-sided Wilcoxon rank sum test
Secondary
Transfusion Requirements - Packed Red Blood Cells
Time frame: Intra-operatively (Day 0) thru Postoperative Day 3
Population: Full Analysis Set - participants with transfusion requirement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (SoC) | Transfusion Requirements - Packed Red Blood Cells | 484.0 mL | Standard Deviation 173.54 |
| FLOSEAL + Standard of Care (SoC) | Transfusion Requirements - Packed Red Blood Cells | 403.3 mL | Standard Deviation 157.9 |
p-value: 0.314two-sided Wilcoxon rank sum test
Secondary
Visual Analogue Scale (VAS) Pain Scores
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Time frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Day 3 Postoperative (N= 45, 42) | 3.2 score on a scale | Standard Deviation 2.6 |
| Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 2 Postoperative (N= 40, 42) | 3.0 score on a scale | Standard Deviation 1.87 |
| Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 1 Postoperative (N= 40, 40) | 4.4 score on a scale | Standard Deviation 2.13 |
| Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 6 Postoperative (N= 49, 46) | 1.3 score on a scale | Standard Deviation 1.34 |
| Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Baseline (N= 50, 47) | 4.9 score on a scale | Standard Deviation 3.03 |
| FLOSEAL + Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 6 Postoperative (N= 49, 46) | 2.4 score on a scale | Standard Deviation 1.86 |
| FLOSEAL + Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Baseline (N= 50, 47) | 4.4 score on a scale | Standard Deviation 2.76 |
| FLOSEAL + Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Day 3 Postoperative (N= 45, 42) | 4.1 score on a scale | Standard Deviation 2.43 |
| FLOSEAL + Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 1 Postoperative (N= 40, 40) | 4.8 score on a scale | Standard Deviation 2.08 |
| FLOSEAL + Standard of Care (SoC) | Visual Analogue Scale (VAS) Pain Scores | Week 2 Postoperative (N= 40, 42) | 3.8 score on a scale | Standard Deviation 2.12 |
Secondary
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues) Postoperative (Postop)
Time frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Physical Functioning (N= 47, 43) | 91.3 score on a scale | Standard Deviation 37.75 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Average (N= 18, 24) | 4.7 score on a scale | Standard Deviation 2.18 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Physical Functioning (N= 15, 16) | 91.7 score on a scale | Standard Deviation 37.9 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Total Score (N= 18, 24) | 112.3 score on a scale | Standard Deviation 52.42 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Total Score (N= 47, 43) | 129.7 score on a scale | Standard Deviation 52.27 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Pain (N= 41, 43) | 15.4 score on a scale | Standard Deviation 8.07 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Average (N= 15, 16) | 5.2 score on a scale | Standard Deviation 2.12 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Stiffness (N= 41, 42) | 8.1 score on a scale | Standard Deviation 4 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Stiffness (N= 50, 47) | 11.9 score on a scale | Standard Deviation 4.86 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Physical Functioning (N= 26, 28) | 51.3 score on a scale | Standard Deviation 25.74 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Total Score (N= 15, 16) | 124.7 score on a scale | Standard Deviation 50.99 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Average (N= 25, 28) | 3.0 score on a scale | Standard Deviation 1.39 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Postoperative: Pain (N= 46, 42) | 19.1 score on a scale | Standard Deviation 11.87 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Total Score (N= 25, 28) | 72.5 score on a scale | Standard Deviation 33.24 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Pain (N= 41, 41) | 23.5 score on a scale | Standard Deviation 11.54 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Pain (N= 49, 47) | 8.5 score on a scale | Standard Deviation 7.6 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Average (N= 47, 43) | 5.4 score on a scale | Standard Deviation 2.18 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Stiffness (N= 49, 46) | 5.5 score on a scale | Standard Deviation 3.64 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Stiffness (N= 41, 40) | 11.8 score on a scale | Standard Deviation 4.57 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Physical Functioning (N= 43, 43) | 27.5 score on a scale | Standard Deviation 25.78 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Postoperative: Stiffness (N= 46, 42) | 10.2 score on a scale | Standard Deviation 4.64 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Average (N= 43, 42) | 1.7 score on a scale | Standard Deviation 1.51 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Physical Functioning (N= 18, 24) | 77.0 score on a scale | Standard Deviation 37.77 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Total Score (N= 43, 42) | 41.6 score on a scale | Standard Deviation 36.24 |
| Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Pain (N= 50, 47) | 26.8 score on a scale | Standard Deviation 11.81 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Total Score (N= 43, 42) | 61.1 score on a scale | Standard Deviation 36.56 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Pain (N= 50, 47) | 27.6 score on a scale | Standard Deviation 10.69 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Stiffness (N= 50, 47) | 11.6 score on a scale | Standard Deviation 5.31 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Physical Functioning (N= 47, 43) | 92.3 score on a scale | Standard Deviation 34.51 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Average (N= 47, 43) | 5.5 score on a scale | Standard Deviation 1.97 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Baseline: Total Score (N= 47, 43) | 130.9 score on a scale | Standard Deviation 47.36 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Postoperative: Pain (N= 46, 42) | 21.5 score on a scale | Standard Deviation 10.28 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Postoperative: Stiffness (N= 46, 42) | 11.1 score on a scale | Standard Deviation 3.37 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Physical Functioning (N= 15, 16) | 97.8 score on a scale | Standard Deviation 37.85 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Average (N= 15, 16) | 5.6 score on a scale | Standard Deviation 2.05 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Day 3 Post-op: Total Score (N= 15, 16) | 133.9 score on a scale | Standard Deviation 49.17 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Pain (N= 41, 41) | 24.5 score on a scale | Standard Deviation 11.25 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Stiffness (N= 41, 40) | 12.2 score on a scale | Standard Deviation 4.48 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Physical Functioning (N= 18, 24) | 76.7 score on a scale | Standard Deviation 41.11 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Average (N= 18, 24) | 4.7 score on a scale | Standard Deviation 2.19 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 1 Post-op: Total Score (N= 18, 24) | 112.3 score on a scale | Standard Deviation 52.66 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Pain (N= 41, 43) | 19.9 score on a scale | Standard Deviation 11.04 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Stiffness (N= 41, 42) | 10.2 score on a scale | Standard Deviation 4.07 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Physical Functioning (N= 26, 28) | 68.5 score on a scale | Standard Deviation 37.2 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Average (N= 25, 28) | 4.1 score on a scale | Standard Deviation 2.09 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 2 Post-op: Total Score (N= 25, 28) | 99.6 score on a scale | Standard Deviation 50.09 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Pain (N= 49, 47) | 12.6 score on a scale | Standard Deviation 7.98 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Stiffness (N= 49, 46) | 7.7 score on a scale | Standard Deviation 3.96 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Physical Functioning (N= 43, 43) | 39.9 score on a scale | Standard Deviation 26.98 |
| FLOSEAL + Standard of Care (SoC) | Western Ontario and McMaster Universities (WOMAC) Function Index Scores | Week 6 Post-op: Average (N= 43, 42) | 2.5 score on a scale | Standard Deviation 1.52 |