Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Conditions
Keywords
REGENETEN, REGENETEN Bioinductive Implant, highgrade partial thickness tear, rotator cuff tear, rotator cuff repair
Brief summary
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.
Detailed description
The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (\>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.
Interventions
DEVICEREGENETEN™ Bioinductive Implant
The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
DEVICEArthroscopic repair of the high-grade (>50%) partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Sponsors
Global Research Solutions
Medical Metrics Diagnostics, Inc
Smith & Nephew, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be considered qualified for enrollment if they meet the following criteria: 1. Male or female ≥18 years 2. High-grade (\>50% tendon thickness) partial-thickness tear 3. Failed conservative medical management of the tendon tear defined as: 1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises 2. Activity modification 3. Shoulder injection at the discretion of the surgeon 4. Able to comply with the post-operative physiotherapy and follow-up schedule 5. Able to speak and read English Provide written informed consent
Exclusion criteria
Any one (1) of the following criteria will disqualify a patient from participation in the study: 1. Prior shoulder surgery on index shoulder within 12 months of enrollment 2. Failed primary rotator cuff surgery of the index shoulder 3. On steroids within 1 month of enrollment 4. Metastatic disease 5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP) 6. Concomitant biceps tenodesis 7. Rheumatoid arthritis 8. Advanced osteoarthritis 9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 10. Chronic pain disorders (i.e., fibromyalgia) 11. History of insulin dependent diabetes 12. History of heavy smoking (\> 1 pack per day) within 6 months of enrollment 13. Currently involved in any injury litigation or workers compensation claims 14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | Baseline and 3 months | American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12 | American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. |
| Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' |
| American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome). |
| American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline, 6 months, 12 months, 18 months and 24 months | American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. |
| Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline, 6 months, 12 months, 18 months and 24 months | Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' |
| American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline, 6 months, 12 months, 18 months and 24 months | Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome). |
| Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | Baseline, 3 months, 6 months, 12 months, and 24 months | Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function & lower scores indicating worse shoulder function. |
| Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. |
| Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. |
| Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery, 6 months, and 12 months | Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. |
| Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery, 6 months, and 12 months | Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. |
| Duration of Shoulder Immobilization | Following index surgery, up to 7 weeks | Duration of shoulder immobilization measured as days spent in a sling |
| Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Up to 12 months | Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as Not currently employed, Did not return to work, Returned to partial, modified, or parttime employment, or Returned to fulltime employment. The type of work for each work status (excluding Not currently employed) was then categorized as: * Very heavy work * Heavy work * Medium work * Light work * Sedentary work |
| Time to Return to Driving | Following index surgery, up to 139 days | Time to return to driving post-index surgery measured in days. |
| Time to Return to Sports | Following index surgery, approximately 1 year | Time to return to sports involving overhead throwing post-index surgery measured in days. |
| Number of Participants Percent Filling of Rotator Cuff at 12 Months | 12 months | The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100% |
| Number of Participants With Progression to Full-Thickness Tear at 24 Months | 24 months | The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact |
| Number of Participants Percent Filling of Rotator Cuff at 24 Months | 24 months | The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100% |
| Number of Unscheduled Clinic Visits | Following index surgery, up to 12 months | The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record. |
| Rotator Cuff Tendon Thickness at 12 Months | 12 Months | Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated) |
| Rotator Cuff Tendon Thickness at 24 Months | 24 Months | Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated) |
| Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | 12 months | The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0 |
| Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | 24 months | The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0 |
| Number of Participants Sugaya Score of Rotator Cuff at 12 Months | 12 months | The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V |
| Number of Participants Sugaya Score of Rotator Cuff at 24 Months | 24 months | The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V |
| Number of Participants With Revision Surgery | Following index surgery, up to 24 months | Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery. |
| Aggregate Health Care Utilization Costs | Following index surgery, up to 12 months | Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records. |
| Operating Room Time (Index Surgery) | Intra-operative | Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes. |
| Number of Steroid Injections | Following index surgery, up to 12 months | The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record. |
| Number of For-Cause Imaging Procedures | Following index surgery, up to 12 months | The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record |
| Number of Physiotherapy Sessions | Following index surgery, up to 12 months | The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record |
| Number of Participants With Progression to Full-Thickness Tear at 12 Months | 12 months | The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact |
Countries
United States
Participant flow
Recruitment details
First participant consented 05 December 2018; study premature termination 14 February 2023 with last participant termination on 11 September 2023.
Pre-assignment details
There were 168 participants enrolled in the study with 50 participants excluded during surgery or prior to surgery that resulted in 118 participants being treated and allocated into treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| REGENETEN™ Bioinductive Implant Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | 59 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. | 59 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 7 |
| Overall Study | Withdrew Consent | 1 | 5 |
Baseline characteristics
| Characteristic | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | REGENETEN™ Bioinductive Implant | Total |
|---|---|---|---|
| Age, Continuous | 58.98 years STANDARD_DEVIATION 8.14 | 52.51 years STANDARD_DEVIATION 10.57 | 55.75 years STANDARD_DEVIATION 9.94 |
| Body Mass Index (BMI) | 29.41 kg/m^2 STANDARD_DEVIATION 4.81 | 31.08 kg/m^2 STANDARD_DEVIATION 8.3 | 30.25 kg/m^2 STANDARD_DEVIATION 6.8 |
| Index shoulder Left | 28 Participants | 19 Participants | 47 Participants |
| Index shoulder Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Index shoulder Right | 31 Participants | 40 Participants | 71 Participants |
| Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain Missing | 54 Participants | 53 Participants | 107 Participants |
| Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain No | 0 Participants | 0 Participants | 0 Participants |
| Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain Yes | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Race / Ethnicity African/Caribbean | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race / Ethnicity American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Missing | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White | 52 Participants | 55 Participants | 107 Participants |
| Region of Enrollment United States | 59 participants | 59 participants | 118 participants |
| Sex: Female, Male Female | 33 Participants | 30 Participants | 63 Participants |
| Sex: Female, Male Male | 26 Participants | 29 Participants | 55 Participants |
| Surgery on Dominant Arm Missing | 10 Participants | 25 Participants | 35 Participants |
| Surgery on Dominant Arm No | 25 Participants | 12 Participants | 37 Participants |
| Surgery on Dominant Arm Yes | 24 Participants | 22 Participants | 46 Participants |
| Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication Missing | 0 Participants | 0 Participants | 0 Participants |
| Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication No | 40 Participants | 44 Participants | 84 Participants |
| Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication Yes | 19 Participants | 15 Participants | 34 Participants |
| Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication Missing | 0 Participants | 0 Participants | 0 Participants |
| Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication No | 51 Participants | 56 Participants | 107 Participants |
| Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication Yes | 8 Participants | 3 Participants | 11 Participants |
| Treatment to Manage Index Shoulder: Shoulder Surgery Missing | 0 Participants | 0 Participants | 0 Participants |
| Treatment to Manage Index Shoulder: Shoulder Surgery No | 57 Participants | 55 Participants | 112 Participants |
| Treatment to Manage Index Shoulder: Shoulder Surgery Yes | 2 Participants | 4 Participants | 6 Participants |
| Treatment to Manage Index Shoulder: Steroid Injection(s) Missing | 0 Participants | 0 Participants | 0 Participants |
| Treatment to Manage Index Shoulder: Steroid Injection(s) No | 28 Participants | 29 Participants | 57 Participants |
| Treatment to Manage Index Shoulder: Steroid Injection(s) Yes | 31 Participants | 30 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 51 / 59 | 56 / 59 |
| serious Total, serious adverse events | 33 / 59 | 17 / 59 |
Outcome results
Primary
American Shoulder and Elbow Surgeons (ASES) Score
American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Time frame: Baseline and 3 months
Population: Overall number of participants with available data for each treatment at the time frame indicated
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score | Baseline | 59.46 score on a scale | Standard Deviation 17.07 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score | 3 months | 80.07 score on a scale | Standard Deviation 13.3 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score | Baseline | 52.10 score on a scale | Standard Deviation 15.61 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score | 3 months | 74.61 score on a scale | Standard Deviation 12.35 |
Secondary
Aggregate Health Care Utilization Costs
Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records.
Time frame: Following index surgery, up to 12 months
Population: Appropriate data not collected to perform analysis as a result of study termination
Secondary
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 94.77 score on a scale | Standard Deviation 13.76 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 59.46 score on a scale | Standard Deviation 17.07 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 90.38 score on a scale | Standard Deviation 11.73 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 90.83 score on a scale | Standard Deviation 16.55 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 94.71 score on a scale | Standard Deviation 13.07 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 92.87 score on a scale | Standard Deviation 13.4 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 91.98 score on a scale | Standard Deviation 12.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 52.10 score on a scale | Standard Deviation 15.61 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 94.17 score on a scale | Standard Deviation 11.76 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 87.42 score on a scale | Standard Deviation 11.25 |
Secondary
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Time frame: Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 78.14 score on a scale | Standard Deviation 11.94 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 57.67 score on a scale | Standard Deviation 13.65 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Baseline | 59.46 score on a scale | Standard Deviation 17.07 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 60.22 score on a scale | Standard Deviation 12.69 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 73.70 score on a scale | Standard Deviation 13.94 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 63.90 score on a scale | Standard Deviation 12.91 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 49.00 score on a scale | Standard Deviation 13.42 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 66.25 score on a scale | Standard Deviation 13.05 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 80.07 score on a scale | Standard Deviation 13.3 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 66.72 score on a scale | Standard Deviation 14.42 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 54.77 score on a scale | Standard Deviation 13.04 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 70.74 score on a scale | Standard Deviation 13.98 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 76.81 score on a scale | Standard Deviation 11.43 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 63.74 score on a scale | Standard Deviation 11.98 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 66.05 score on a scale | Standard Deviation 12.54 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 69.62 score on a scale | Standard Deviation 11.69 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 71.80 score on a scale | Standard Deviation 13.43 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 74.61 score on a scale | Standard Deviation 12.35 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Baseline | 52.10 score on a scale | Standard Deviation 15.61 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 44.42 score on a scale | Standard Deviation 11.22 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 50.04 score on a scale | Standard Deviation 12.92 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 51.77 score on a scale | Standard Deviation 12.62 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 51.77 score on a scale | Standard Deviation 11.19 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 56.89 score on a scale | Standard Deviation 9.84 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 59.06 score on a scale | Standard Deviation 11.77 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 62.18 score on a scale | Standard Deviation 12.66 |
Secondary
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 0.48 score on a scale | Standard Deviation 1.61 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 4.35 score on a scale | Standard Deviation 2.54 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 0.79 score on a scale | Standard Deviation 1.56 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 1.09 score on a scale | Standard Deviation 2.12 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 0.50 score on a scale | Standard Deviation 1.56 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 0.77 score on a scale | Standard Deviation 1.75 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 0.47 score on a scale | Standard Deviation 1.15 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 0.68 score on a scale | Standard Deviation 1.62 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 5.49 score on a scale | Standard Deviation 2.49 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 0.89 score on a scale | Standard Deviation 1.38 |
Secondary
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 2.65 score on a scale | Standard Deviation 2.1 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 2.15 score on a scale | Standard Deviation 1.94 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Baseline | 4.35 score on a scale | Standard Deviation 2.54 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 2.20 score on a scale | Standard Deviation 2.13 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 3.03 score on a scale | Standard Deviation 2.14 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 2.42 score on a scale | Standard Deviation 2.09 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 1.57 score on a scale | Standard Deviation 1.91 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 3.53 score on a scale | Standard Deviation 2.27 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 1.32 score on a scale | Standard Deviation 1.55 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 1.27 score on a scale | Standard Deviation 1.62 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 2.32 score on a scale | Standard Deviation 1.99 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 1.31 score on a scale | Standard Deviation 1.83 |
| REGENETEN™ Bioinductive Implant | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 1.79 score on a scale | Standard Deviation 2.01 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 1.79 score on a scale | Standard Deviation 1.75 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Baseline | 5.49 score on a scale | Standard Deviation 2.49 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 4.15 score on a scale | Standard Deviation 2.23 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 3.49 score on a scale | Standard Deviation 2.02 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 3.29 score on a scale | Standard Deviation 2.25 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 1.97 score on a scale | Standard Deviation 1.58 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 3.34 score on a scale | Standard Deviation 1.98 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 2.84 score on a scale | Standard Deviation 1.64 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 2.77 score on a scale | Standard Deviation 1.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 2.58 score on a scale | Standard Deviation 1.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 2.41 score on a scale | Standard Deviation 1.66 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 2.41 score on a scale | Standard Deviation 1.73 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 1.92 score on a scale | Standard Deviation 2 |
Secondary
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function & lower scores indicating worse shoulder function.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | 71.76 score on a scale | Standard Deviation 8.65 |
| REGENETEN™ Bioinductive Implant | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | Baseline | 53.73 score on a scale | Standard Deviation 15.81 |
| REGENETEN™ Bioinductive Implant | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | 60.73 score on a scale | Standard Deviation 12.05 |
| REGENETEN™ Bioinductive Implant | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | 66.10 score on a scale | Standard Deviation 10.57 |
| REGENETEN™ Bioinductive Implant | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | 69.33 score on a scale | Standard Deviation 11.11 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | 66.24 score on a scale | Standard Deviation 12.45 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | 61.13 score on a scale | Standard Deviation 11.62 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | Baseline | 45.40 score on a scale | Standard Deviation 14.13 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | 71.18 score on a scale | Standard Deviation 9.08 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | 52.35 score on a scale | Standard Deviation 12.08 |
Secondary
Duration of Shoulder Immobilization
Duration of shoulder immobilization measured as days spent in a sling
Time frame: Following index surgery, up to 7 weeks
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Duration of Shoulder Immobilization | 18.40 days | Standard Deviation 14.55 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Duration of Shoulder Immobilization | 35.72 days | Standard Deviation 12.55 |
Secondary
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Time frame: Directly after surgery, 6 months, and 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery | 6.94 defined daily dose | Standard Deviation 3.2 |
| REGENETEN™ Bioinductive Implant | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | 6 months | 3.20 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery | 2.67 defined daily dose | Standard Deviation 0.89 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | 6 months | 19.00 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | 12 months | 2.00 defined daily dose | — |
Secondary
Number of For-Cause Imaging Procedures
The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record
Time frame: Following index surgery, up to 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of For-Cause Imaging Procedures | 2.27 for-cause imaging procedures | Standard Deviation 2.28 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of For-Cause Imaging Procedures | 1.50 for-cause imaging procedures | Standard Deviation 0.85 |
Secondary
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Time frame: 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 1 | 15 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 2 | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 3 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 4 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 0 | 7 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 1 | 12 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 2 | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 3 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 4 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 0 | 11 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 3 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 1 | 13 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 1 | 16 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 2 | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 0 | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 3 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 2 | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 4 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=No | Grade 4 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | Bursal=Yes | Grade 0 | 6 Participants |
Secondary
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Time frame: 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 1 | 13 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 2 | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 3 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 4 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 0 | 8 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 1 | 11 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 2 | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 3 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 4 | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 0 | 11 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 3 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 1 | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 1 | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 2 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 0 | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 3 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 2 | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 4 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=No | Grade 4 | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | Bursal=Yes | Grade 0 | 2 Participants |
Secondary
Number of Participants Percent Filling of Rotator Cuff at 12 Months
The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Time frame: 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 0% to < 25% | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 25% to < 50% | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 50% to < 75% | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 75% to < 100% | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 100% | 4 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 0% to < 25% | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 25% to < 50% | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 50% to < 75% | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 75% to < 100% | 10 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 100% | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 50% to < 75% | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 0% to < 25% | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 0% to < 25% | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 25% to < 50% | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 100% | 11 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 50% to < 75% | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 25% to < 50% | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 75% to < 100% | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=No | 75% to < 100% | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 12 Months | Bursal=Yes | 100% | 4 Participants |
Secondary
Number of Participants Percent Filling of Rotator Cuff at 24 Months
The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Time frame: 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 0% to < 25% | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 25% to < 50% | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 50% to < 75% | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 75% to < 100% | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 100% | 7 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 0% to < 25% | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 25% to < 50% | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 50% to < 75% | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 75% to < 100% | 10 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 100% | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 50% to < 75% | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 0% to < 25% | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 0% to < 25% | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 25% to < 50% | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 100% | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 50% to < 75% | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 25% to < 50% | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 75% to < 100% | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=No | 75% to < 100% | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Percent Filling of Rotator Cuff at 24 Months | Bursal=Yes | 100% | 1 Participants |
Secondary
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as Not currently employed, Did not return to work, Returned to partial, modified, or parttime employment, or Returned to fulltime employment. The type of work for each work status (excluding Not currently employed) was then categorized as: * Very heavy work * Heavy work * Medium work * Light work * Sedentary work
Time frame: Up to 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated. It was possible for participants to return to partial, modified, or part-time employment, and then return to fulltime employment within the 12 month period. Meaning, multiple responses were allowed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Not currently employed | 16 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Very heavy work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Heavy work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Medium work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Light work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Sedentary work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Very heavy work | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Heavy work | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Medium work | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Light work | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Sedentary work | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Very heavy work | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Heavy work | 4 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Medium work | 8 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Light work | 10 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Sedentary work | 8 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Sedentary work | 11 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Not currently employed | 20 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Medium work | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Very heavy work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Heavy work | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Heavy work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Light work | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Medium work | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Light work | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Light work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Sedentary work | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Did not return to work : Sedentary work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Medium work | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Very heavy work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to fulltime employment : Very heavy work | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Returned to partial, modified, or parttime employment : Heavy work | 2 Participants |
Secondary
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Time frame: 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type I | 4 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type II | 8 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type III | 8 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type IV | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type V | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type I | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type II | 12 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type III | 8 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type IV | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type V | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type III | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type I | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type I | 11 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type II | 8 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type V | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type III | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type II | 10 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type IV | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=No | Type IV | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | Bursal=Yes | Type V | 0 Participants |
Secondary
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Time frame: 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type I | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type I | 7 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type III | 4 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type II | 14 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type V | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type III | 4 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type IV | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type IV | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type II | 10 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type V | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type V | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type I | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type II | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type III | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type IV | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=Yes | Type V | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type I | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type II | 8 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type III | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | Bursal=No | Type IV | 0 Participants |
Secondary
Number of Participants With Progression to Full-Thickness Tear at 12 Months
The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Time frame: 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | High-grade Partial Thickness Tear | 7 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Tendinosis | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Low-grade Partial Thickness Tear | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Low-grade Partial Thickness Tear | 12 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Full-Thickness Tear | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | High-grade Partial Thickness Tear | 6 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Tendinosis | 7 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Full-Thickness Tear | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Intact | 2 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Intact | 3 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Intact | 9 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Tendinosis | 8 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Low-grade Partial Thickness Tear | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | High-grade Partial Thickness Tear | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Full-Thickness Tear | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=Yes | Intact | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Tendinosis | 7 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Low-grade Partial Thickness Tear | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | High-grade Partial Thickness Tear | 5 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 12 Months | Bursal=No | Full-Thickness Tear | 0 Participants |
Secondary
Number of Participants With Progression to Full-Thickness Tear at 24 Months
The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Time frame: 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Tendinosis | 10 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Low-grade Partial Thickness Tear | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | High-grade Partial Thickness Tear | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Full-Thickness Tear | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Intact | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Tendinosis | 5 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Low-grade Partial Thickness Tear | 13 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | High-grade Partial Thickness Tear | 3 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Full-Thickness Tear | 0 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Intact | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | High-grade Partial Thickness Tear | 1 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Tendinosis | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Tendinosis | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Low-grade Partial Thickness Tear | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Intact | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | High-grade Partial Thickness Tear | 2 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Low-grade Partial Thickness Tear | 6 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Full-Thickness Tear | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=No | Full-Thickness Tear | 0 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Progression to Full-Thickness Tear at 24 Months | Bursal=Yes | Intact | 0 Participants |
Secondary
Number of Participants With Revision Surgery
Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery.
Time frame: Following index surgery, up to 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Participants With Revision Surgery | Revision Surgery: Yes | 1 Participants |
| REGENETEN™ Bioinductive Implant | Number of Participants With Revision Surgery | Revision Surgery: No | 58 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Revision Surgery | Revision Surgery: Yes | 4 Participants |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Participants With Revision Surgery | Revision Surgery: No | 55 Participants |
Secondary
Number of Physiotherapy Sessions
The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record
Time frame: Following index surgery, up to 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Physiotherapy Sessions | 18.40 physiotherapy sessions | Standard Deviation 8.23 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Physiotherapy Sessions | 27.84 physiotherapy sessions | Standard Deviation 13.41 |
Secondary
Number of Steroid Injections
The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record.
Time frame: Following index surgery, up to 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Steroid Injections | 1.58 injections | Standard Deviation 1 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Steroid Injections | 1.60 injections | Standard Deviation 1 |
Secondary
Number of Unscheduled Clinic Visits
The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record.
Time frame: Following index surgery, up to 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Number of Unscheduled Clinic Visits | 4.1 unscheduled visits | Standard Deviation 1.94 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Number of Unscheduled Clinic Visits | 5.16 unscheduled visits | Standard Deviation 2.08 |
Secondary
Operating Room Time (Index Surgery)
Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes.
Time frame: Intra-operative
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Operating Room Time (Index Surgery) | 46.89 minutes | Standard Deviation 19.13 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Operating Room Time (Index Surgery) | 57.05 minutes | Standard Deviation 19.16 |
Secondary
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Time frame: Directly after surgery, 6 months, and 12 months
Population: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery | 7.82 defined daily dose | Standard Deviation 22.93 |
| REGENETEN™ Bioinductive Implant | Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | 6 months | 2.40 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Directly after surgery | 3.10 defined daily dose | Standard Deviation 7.53 |
Secondary
Rotator Cuff Tendon Thickness at 12 Months
Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Time frame: 12 Months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 12 Months | Total Thickness (where tendon thickness cannot be differentiated) | 4.45 millimeters (mm) | Standard Deviation 1.86 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 12 Months | Thickness of Native (where tendon thickness can be differentiated) | 3.50 millimeters (mm) | Standard Deviation 0.85 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 12 Months | Thickness of New Tissue (where tendon thickness can be differentiated) | 2.40 millimeters (mm) | Standard Deviation 0.42 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 12 Months | Total Thickness (where tendon thickness can be differentiated) | 5.90 millimeters (mm) | Standard Deviation 0.77 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 12 Months | Total Thickness (where tendon thickness can be differentiated) | 4.40 millimeters (mm) | Standard Deviation 1.6 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 12 Months | Total Thickness (where tendon thickness cannot be differentiated) | 4.57 millimeters (mm) | Standard Deviation 1.75 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 12 Months | Thickness of New Tissue (where tendon thickness can be differentiated) | 2.53 millimeters (mm) | Standard Deviation 0.79 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 12 Months | Thickness of Native (where tendon thickness can be differentiated) | 1.87 millimeters (mm) | Standard Deviation 1.13 |
Secondary
Rotator Cuff Tendon Thickness at 24 Months
Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Time frame: 24 Months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 24 Months | Total Thickness (where tendon thickness cannot be differentiated) | 4.88 millimeters (mm) | Standard Deviation 1.9 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 24 Months | Thickness of Native (where tendon thickness can be differentiated) | 4.00 millimeters (mm) | Standard Deviation 0.91 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 24 Months | Thickness of New Tissue (where tendon thickness can be differentiated) | 2.38 millimeters (mm) | Standard Deviation 0.41 |
| REGENETEN™ Bioinductive Implant | Rotator Cuff Tendon Thickness at 24 Months | Total Thickness (where tendon thickness can be differentiated) | 6.38 millimeters (mm) | Standard Deviation 0.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 24 Months | Total Thickness (where tendon thickness can be differentiated) | 5.70 millimeters (mm) | Standard Deviation 0.28 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 24 Months | Total Thickness (where tendon thickness cannot be differentiated) | 4.63 millimeters (mm) | Standard Deviation 1.47 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 24 Months | Thickness of New Tissue (where tendon thickness can be differentiated) | 2.90 millimeters (mm) | Standard Deviation 0.85 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Rotator Cuff Tendon Thickness at 24 Months | Thickness of Native (where tendon thickness can be differentiated) | 2.80 millimeters (mm) | Standard Deviation 1.13 |
Secondary
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 86.18 score on a scale | Standard Deviation 12.47 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 91.74 score on a scale | Standard Deviation 12.52 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 87.27 score on a scale | Standard Deviation 17.35 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 90.67 score on a scale | Standard Deviation 19.17 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 47.42 score on a scale | Standard Deviation 21.34 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 24 months | 94.20 score on a scale | Standard Deviation 8.07 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Baseline | 36.78 score on a scale | Standard Deviation 17.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 6 months | 81.15 score on a scale | Standard Deviation 14.12 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 12 months | 87.86 score on a scale | Standard Deviation 14.64 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | 18 months | 90.03 score on a scale | Standard Deviation 10.3 |
Secondary
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 35.37 score on a scale | Standard Deviation 20.93 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 56.35 score on a scale | Standard Deviation 18.59 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 45.73 score on a scale | Standard Deviation 16.76 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 59.91 score on a scale | Standard Deviation 19.88 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 28.22 score on a scale | Standard Deviation 21.63 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 61.82 score on a scale | Standard Deviation 18.22 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 49.00 score on a scale | Standard Deviation 17.18 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 67.66 score on a scale | Standard Deviation 16.23 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 39.89 score on a scale | Standard Deviation 18.79 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 69.86 score on a scale | Standard Deviation 14.8 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 54.60 score on a scale | Standard Deviation 16.83 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 73.31 score on a scale | Standard Deviation 16.38 |
| REGENETEN™ Bioinductive Implant | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Baseline | 47.42 score on a scale | Standard Deviation 21.34 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 12 | 63.89 score on a scale | Standard Deviation 16.11 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Baseline | 36.78 score on a scale | Standard Deviation 17.9 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 1 | 17.85 score on a scale | Standard Deviation 17.23 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 2 | 24.27 score on a scale | Standard Deviation 17.86 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 3 | 31.94 score on a scale | Standard Deviation 16.35 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 4 | 42.27 score on a scale | Standard Deviation 17.18 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 5 | 40.19 score on a scale | Standard Deviation 18.56 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 6 | 42.27 score on a scale | Standard Deviation 17.18 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 7 | 46.56 score on a scale | Standard Deviation 16.48 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 8 | 49.77 score on a scale | Standard Deviation 15.81 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 9 | 53.55 score on a scale | Standard Deviation 15.17 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 10 | 57.27 score on a scale | Standard Deviation 15.15 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Week 11 | 59.45 score on a scale | Standard Deviation 18.04 |
Secondary
Time to Return to Driving
Time to return to driving post-index surgery measured in days.
Time frame: Following index surgery, up to 139 days
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Time to Return to Driving | 18.3 days | Standard Deviation 21.6 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Time to Return to Driving | 24.54 days | Standard Deviation 19.85 |
Secondary
Time to Return to Sports
Time to return to sports involving overhead throwing post-index surgery measured in days.
Time frame: Following index surgery, approximately 1 year
Population: Overall number of participants with available data for the treatment and time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Time to Return to Sports | 202 days | Standard Deviation 87.18 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Time to Return to Sports | 93.50 days | Standard Deviation 17.68 |
Secondary
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Time frame: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Population: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 1 | 10.50 defined daily dose | Standard Deviation 7.67 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery | 6.94 defined daily dose | Standard Deviation 3.2 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 2 | 10.50 defined daily dose | Standard Deviation 8.71 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 3 | 20.00 defined daily dose | Standard Deviation 0 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 4 | 20.00 defined daily dose | Standard Deviation 0 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 5 | 14.78 defined daily dose | Standard Deviation 9.05 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 6 | 13.83 defined daily dose | Standard Deviation 10.68 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 7 | 14.00 defined daily dose | Standard Deviation 10.39 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 8 | 15.83 defined daily dose | Standard Deviation 7.22 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 9 | 16.00 defined daily dose | Standard Deviation 4 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 10 | 12.00 defined daily dose | Standard Deviation 11.31 |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 11 | 20.00 defined daily dose | — |
| REGENETEN™ Bioinductive Implant | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 12 | 27.00 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 12 | 11.27 defined daily dose | Standard Deviation 15.18 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 1 | 4.21 defined daily dose | Standard Deviation 6.24 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 10 | 5.83 defined daily dose | Standard Deviation 4.86 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 6 | 5.63 defined daily dose | Standard Deviation 3.96 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery | 2.67 defined daily dose | Standard Deviation 0.89 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 9 | 5.01 defined daily dose | Standard Deviation 5.2 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 2 | 5.05 defined daily dose | Standard Deviation 6.86 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 7 | 5.17 defined daily dose | Standard Deviation 3.48 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 3 | 3.47 defined daily dose | Standard Deviation 2.79 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 11 | 5.17 defined daily dose | Standard Deviation 5.42 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 4 | 1.48 defined daily dose | Standard Deviation 0.87 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 8 | 6.75 defined daily dose | Standard Deviation 7.42 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 5 | 4.22 defined daily dose | Standard Deviation 3.85 |
Secondary
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Time frame: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Population: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 6 | 0.97 defined daily dose | Standard Deviation 0.99 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 2 | 4.38 defined daily dose | Standard Deviation 6.12 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 4 | 2.81 defined daily dose | Standard Deviation 1.64 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 1 | 18.28 defined daily dose | Standard Deviation 42.9 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 5 | 1.17 defined daily dose | Standard Deviation 0.85 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 3 | 3.85 defined daily dose | Standard Deviation 3.21 |
| REGENETEN™ Bioinductive Implant | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery | 7.82 defined daily dose | Standard Deviation 22.93 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 6 | 1.98 defined daily dose | Standard Deviation 2.04 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 7 | 1.56 defined daily dose | Standard Deviation 2.44 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 8 | 0.66 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 9 | 2.11 defined daily dose | Standard Deviation 1.71 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 10 | 2.50 defined daily dose | — |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 11 | 2.34 defined daily dose | Standard Deviation 2.35 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Directly after surgery | 3.10 defined daily dose | Standard Deviation 7.53 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 1 | 4.22 defined daily dose | Standard Deviation 10.93 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 2 | 1.73 defined daily dose | Standard Deviation 2.05 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 3 | 3.35 defined daily dose | Standard Deviation 5.12 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 4 | 2.58 defined daily dose | Standard Deviation 2.2 |
| Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Week 5 | 1.97 defined daily dose | Standard Deviation 2.01 |