Pain
Conditions
Keywords
CryoAnalgesia, Thoracotomy, Forced Expiratory Volume (FEV1), Visual Analog Scale (VAS)
Brief summary
The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.
Detailed description
Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.
Interventions
DEVICECryoanalgesia
AtriCure® cryoICE cryo-ablation system
DRUGStandard of Care
Institutional SOC for pain management will be followed.
Sponsors
AtriCure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 85 years male or female * Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment) * Acceptable surgical candidate, including use of general anesthesia * Willing and able to provide written informed consent * Willing and able to return for scheduled follow-up visits
Exclusion criteria
* Cardiac valve surgical procedure via conventional full sternotomy * Procedures that require a posterolateral thoracotomy * Current pregnancy * Current use of prescription opioids * FEV1 \< 40% predicted * Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF) * Documented psychiatric disease * Documented chronic pain syndrome * Documented history of substance abuse * Patient currently enrolled in another research study that could directly affect results of either study * Physical or mental condition that would interfere with patient's self-assessment of pain * Disqualifying medical condition per investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery | 48-hours post-surgery | Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device. |
| Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery | 48-hours post-surgery | The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | 3 and 6 Months | Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place. |
| Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room | Hours until patient is extubated from time patient leaves the operating room | Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea. |
| Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | 48-hours post-extubation | Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced. |
| Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | Procedure to Discharge | The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay. |
| Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline, 48, 72, 96, 120 Hours and Discharge | Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay. |
| Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 24-, 48, -96 and 120-hours | Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay. |
| Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 72-, 96- and 120-hours Post-Op | The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryoanalgesia + Standard of Care (SOC) Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Cryoanalgesia: AtriCure® cryoICE cryo-ablation system
Standard of Care: Institutional SOC for pain management will be followed. | 65 |
| Standard of Care Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.
Standard of Care: Institutional SOC for pain management will be followed. | 19 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 8 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | Cryoanalgesia + Standard of Care (SOC) | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 63.83 years STANDARD_DEVIATION 11.96 | 66.42 years STANDARD_DEVIATION 12.53 | 64.42 years STANDARD_DEVIATION 12.06 |
| Body Mass Index (BMI) | 28.61 kg/m^2 STANDARD_DEVIATION 5.03 | 29.95 kg/m^2 STANDARD_DEVIATION 4.73 | 28.91 kg/m^2 STANDARD_DEVIATION 4.96 |
| Forced Expiratory Value (FEV1) | 2.33 Liters (L) STANDARD_DEVIATION 0.78 | 2.28 Liters (L) STANDARD_DEVIATION 0.84 | 2.32 Liters (L) STANDARD_DEVIATION 0.79 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 59 Participants | 18 Participants | 77 Participants |
| Region of Enrollment United States | 65 participants | 19 participants | 84 participants |
| Sex: Female, Male Female | 27 Participants | 8 Participants | 35 Participants |
| Sex: Female, Male Male | 38 Participants | 11 Participants | 49 Participants |
| Society of Thoracic Surgeon Score (STS) | 2.03 Percentage STANDARD_DEVIATION 1.9 | 2.86 Percentage STANDARD_DEVIATION 2.57 | 2.23 Percentage STANDARD_DEVIATION 2.09 |
| Visual Analog Scale (general) | 0.32 units on a scale STANDARD_DEVIATION 0.95 | 0.42 units on a scale STANDARD_DEVIATION 0.9 | 0.35 units on a scale STANDARD_DEVIATION 0.94 |
| Visual Analog Scale (surgical site) | 0.03 units on a scale STANDARD_DEVIATION 0.25 | 0.21 units on a scale STANDARD_DEVIATION 0.54 | 0.07 units on a scale STANDARD_DEVIATION 0.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 65 | 1 / 19 |
| other Total, other adverse events | 2 / 65 | 0 / 19 |
| serious Total, serious adverse events | 0 / 65 | 0 / 19 |
Outcome results
Primary
Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.
Time frame: 48-hours post-surgery
Population: Includes all patients who were consented and randomized (84). Not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for Cryoanalgesia (CRYO) + SOC and 16/19 subjects for SOC.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cryoanalgesia + SOC | Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery | 1.2 Liters (L) |
| Standard of Care | Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery | 0.93 Liters (L) |
p-value: 0.0223t-test, 1 sided
Primary
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Time frame: 48-hours post-surgery
Population: Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 61/64 subject for CRYO + SOC and 18/19 subjects for SOC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoanalgesia + SOC | Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery | 2.82 units on a scale | Standard Deviation 2.7 |
| Standard of Care | Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery | 3.06 units on a scale | Standard Deviation 2.82 |
p-value: 0.6259t-test, 1 sided
p-value: 0.518Wilcoxon (Mann-Whitney)
Secondary
Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation
Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.
Time frame: 48-hours post-extubation
Population: Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for CRYO + SOC and 16/19 subjects for SOC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | FEV1 | 1.20 Liters (L) | Standard Deviation 0.46 |
| Cryoanalgesia + SOC | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | SVC | 1.52 Liters (L) | Standard Deviation 0.61 |
| Cryoanalgesia + SOC | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | FVC | 1.60 Liters (L) | Standard Deviation 0.62 |
| Standard of Care | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | FEV1 | 0.93 Liters (L) | Standard Deviation 0.43 |
| Standard of Care | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | FVC | 1.33 Liters (L) | Standard Deviation 0.55 |
| Standard of Care | Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | SVC | 1.28 Liters (L) | Standard Deviation 0.55 |
p-value: 0.0201t-test, 1 sided
p-value: 0.06t-test, 1 sided
p-value: 0.09t-test, 1 sided
Secondary
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points
The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Time frame: 72-, 96- and 120-hours Post-Op
Population: Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 96 Hours Post-Op | 1.84 units on a scale | Standard Deviation 2.39 |
| Cryoanalgesia + SOC | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 72 Hours Post-Op | 2.08 units on a scale | Standard Deviation 2.39 |
| Cryoanalgesia + SOC | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 120 Hours Post-Op | 2.50 units on a scale | Standard Deviation 2.82 |
| Standard of Care | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 72 Hours Post-Op | 1.44 units on a scale | Standard Deviation 2.09 |
| Standard of Care | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 96 Hours Post-Op | 2.00 units on a scale | Standard Deviation 2.45 |
| Standard of Care | Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | 120 Hours Post-Op | 2.40 units on a scale | Standard Deviation 3.37 |
p-value: 0.3085Wilcoxon (Mann-Whitney)
p-value: 0.8196Wilcoxon (Mann-Whitney)
p-value: 0.7269Wilcoxon (Mann-Whitney)
Secondary
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit
Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.
Time frame: 3 and 6 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | 3 Month | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | 6 Month | 1 Participants |
| Standard of Care | Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | 3 Month | 0 Participants |
| Standard of Care | Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | 6 Month | 0 Participants |
Secondary
Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room
Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.
Time frame: Hours until patient is extubated from time patient leaves the operating room
Population: Overall number is for all patients that were fully extubated and accounts for patients who were unable to be extubated or did were unable to finish extubation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room | 8.85 Hours | Standard Deviation 11.16 |
| Standard of Care | Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room | 7.33 Hours | Standard Deviation 4.51 |
Comparison: Analysis is the time from end of procedure to oral endotracheal extubationp-value: 0.4421Wilcoxon (Mann-Whitney)
Secondary
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points
Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.
Time frame: 24-, 48, -96 and 120-hours
Population: Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 24 Hours | 11.43 Morphine Milligram Equivalent (MME) | Standard Deviation 14.54 |
| Cryoanalgesia + SOC | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 120 Hours | 14.10 Morphine Milligram Equivalent (MME) | Standard Deviation 18.58 |
| Cryoanalgesia + SOC | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 96 Hours | 14.87 Morphine Milligram Equivalent (MME) | Standard Deviation 19.82 |
| Cryoanalgesia + SOC | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | Total Post-Procedure for Hospital Stay | 33.43 Morphine Milligram Equivalent (MME) | Standard Deviation 29.77 |
| Cryoanalgesia + SOC | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 48 Hours | 20.91 Morphine Milligram Equivalent (MME) | Standard Deviation 23.45 |
| Standard of Care | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | Total Post-Procedure for Hospital Stay | 38.31 Morphine Milligram Equivalent (MME) | Standard Deviation 31.05 |
| Standard of Care | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 48 Hours | 31.05 Morphine Milligram Equivalent (MME) | Standard Deviation 36.02 |
| Standard of Care | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 24 Hours | 17.32 Morphine Milligram Equivalent (MME) | Standard Deviation 23.65 |
| Standard of Care | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 96 Hours | 16.67 Morphine Milligram Equivalent (MME) | Standard Deviation 44.52 |
| Standard of Care | Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | 120 Hours | 13.13 Morphine Milligram Equivalent (MME) | Standard Deviation 20.4 |
p-value: 0.4352Wilcoxon (Mann-Whitney)
Secondary
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge
The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.
Time frame: Procedure to Discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | ICU Length of Stay | 4.96 Days | Standard Deviation 7.75 |
| Cryoanalgesia + SOC | Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | Hospital Length of Stay | 9.40 Days | Standard Deviation 8.34 |
| Standard of Care | Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | ICU Length of Stay | 2.96 Days | Standard Deviation 2.24 |
| Standard of Care | Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | Hospital Length of Stay | 6.32 Days | Standard Deviation 2.56 |
p-value: 0.2939Wilcoxon (Mann-Whitney)
p-value: 0.0998Wilcoxon (Mann-Whitney)
Secondary
Secondary Outcome 7: Ambulatory Movement During Hospital Stay
Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.
Time frame: Baseline, 48, 72, 96, 120 Hours and Discharge
Population: Initial patient population was 65 and 19 for the CRYO arm and SOC arm respectively. Number of patients analysed at the time points below differs due to the following: patient unwilling or refused test, patient discharged from hospital or other patient hospital stay issues.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | Yes - with assistance | 1 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | Yes - Independently | 63 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | Yes - with assistance | 1 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | Yes - Independently | 34 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | Yes - Independently | 21 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | Yes - Independently | 16 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | Yes - with assistance | 38 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | Yes - Independently | 26 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | Yes - Independently | 43 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | Yes - Independently | 47 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | Yes - with assistance | 12 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | Yes - Independently | 39 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | Yes - with assistance | 20 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | Yes - Independently | 28 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | Yes - with assistance | 27 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | No | 4 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | Yes - Independently | 41 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | Yes - Independently | 32 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | Yes - with assistance | 17 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | Yes - Independently | 51 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | Yes - Independently | 64 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | Yes - Independently | 65 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | Yes - with assistance | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | Yes - Independently | 64 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | Yes - with assistance | 1 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | Yes - with assistance | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | Yes - Independently | 64 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | Yes - with assistance | 27 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | Yes - with assistance | 38 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | No | 7 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | Yes - with assistance | 33 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | Yes - with assistance | 16 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | Yes - with assistance | 17 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | No | 1 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | Yes - Independently | 49 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | Yes - with assistance | 8 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | Yes - Independently | 41 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | Yes - with assistance | 10 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | Yes - with assistance | 19 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | Yes - Independently | 26 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | Yes - with assistance | 21 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | No | 4 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | Yes - Independently | 39 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | Yes - with assistance | 11 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | No | 1 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | Yes - Independently | 43 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | Yes - with assistance | 6 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | Yes - Independently | 36 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | Yes - with assistance | 6 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | Yes - Independently | 30 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | Yes - with assistance | 12 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | Yes - Independently | 23 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | Yes - Independently | 34 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | Yes - with assistance | 8 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | Yes - Independently | 37 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | Yes - with assistance | 5 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | Yes - Independently | 53 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | Yes - with assistance | 7 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | Yes - with assistance | 7 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | Yes - Independently | 50 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | Yes - with assistance | 8 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | No | 2 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | Yes - Independently | 54 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | Yes - with assistance | 6 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | No | 0 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | Yes - Independently | 51 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | Yes - with assistance | 5 Participants |
| Cryoanalgesia + SOC | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | No | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | Yes - Independently | 15 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | Yes - Independently | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | Yes - with assistance | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | Yes - with assistance | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | Yes - with assistance | 10 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | Yes - Independently | 17 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | Yes - Independently | 12 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to walk | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | No | 1 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | Yes - with assistance | 3 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | Yes - Independently | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | Yes - with assistance | 13 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | Yes - Independently | 9 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | Yes - with assistance | 6 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | Yes - Independently | 12 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | Yes - with assistance | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | Yes - Independently | 8 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | No | 1 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | Yes - with assistance | 9 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | Yes - with assistance | 1 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | Yes - Independently | 7 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | Yes - Independently | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | Yes - Independently | 16 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | Yes - with assistance | 10 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | Yes - with assistance | 7 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | Yes - Independently | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Right shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | Yes - with assistance | 11 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to walk | No | 1 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to walk | No | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to stand up | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | Yes - Independently | 11 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Able to stand up | Yes - Independently | 8 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | Yes - Independently | 10 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | Yes - with assistance | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | Yes - with assistance | 3 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Right shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | Yes - with assistance | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | Yes - Independently | 13 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | Yes - with assistance | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to stand up | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | Yes - Independently | 15 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Able to walk | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 96 Hours - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Left shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Right shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | Yes - Independently | 7 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Baseline - Left shoulder flexion movement | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to sit up in bed | Yes - Independently | 7 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Right shoulder flexion movement | Yes - with assistance | 3 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | Yes - Independently | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | Yes - with assistance | 3 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to stand up | Yes - with assistance | 12 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | Yes - Independently | 19 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Able to walk | No | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | Yes - Independently | 8 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to sit up in bed | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | Yes - with assistance | 8 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Left shoulder flexion movement | Yes - Independently | 16 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Right shoulder flexion movement | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | Yes - Independently | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 48 Hours - Left shoulder flexion movement | Yes - with assistance | 4 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to sit up in bed | Yes - with assistance | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | Yes - with assistance | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Able to stand up | No | 2 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | Yes - Independently | 12 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Discharge - Able to walk | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | Yes - with assistance | 5 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 120 Hours - Able to stand up | No | 0 Participants |
| Standard of Care | Secondary Outcome 7: Ambulatory Movement During Hospital Stay | 72 Hours - Right shoulder flexion movement | No | 0 Participants |
Comparison: 48 Hours Post-Op: Patient able to walkp-value: 0.4908Fisher Exact
Comparison: 48 Hours Post-Op: Patient able to sit up in bedp-value: 0.2877Chi-squared
Comparison: 48 Hours Post-Op: Patient able to stand upp-value: 0.5311Fisher Exact
Comparison: 48 Hours Post-Op: Right Shoulder Flexion Movementp-value: 0.8621Fisher Exact
Comparison: 48 Hours Post-Op: Left Shoulder Flexion Movementp-value: 1Fisher Exact
Comparison: 72 Hours Post-Op: Patient able to sit up in bedp-value: 0.0133Fisher Exact
Comparison: 72 Hours Post-Op: Patient able to stand upp-value: 0.0037Fisher Exact
Comparison: 72 Hours Post-Op: Patient able to walkp-value: 0.1671Fisher Exact
Comparison: 72 Hours Post-Op: Right Shoulder Flexion Movementp-value: 1Fisher Exact
Comparison: 72 Hours Post-Op: Left Shoulder Flexion Movementp-value: 1Fisher Exact
Comparison: 96 Hours Post-Op: Patient able to sit up in bedp-value: 1Fisher Exact
Comparison: 96 Hours Post-Op: Patient able to stand upp-value: 0.2757Fisher Exact
Comparison: 96 Hours Post-Op: Patient able to walkp-value: 0.9025Fisher Exact
Comparison: 96 Hours Post-Op: Right Shoulder Flexion Movementp-value: 0.7942Fisher Exact
Comparison: 96 Hours Post-Op: Left Shoulder Flexion Movementp-value: 1Fisher Exact
Comparison: 120 Hours Post-Op: Patient able to sit up in bedp-value: 0.3492Fisher Exact
Comparison: 120 Hours Post-Op: Patient able to stand upp-value: 0.2644Fisher Exact
Comparison: 120 Hours Post-Op: Patient able to walkp-value: 0.8258Fisher Exact
Comparison: 120 Hours Post-Op: Right Shoulder Flexion Movementp-value: 0.67Fisher Exact
Comparison: 120 Hours Post-Op: Left Shoulder Flexion Movementp-value: 0.5693Fisher Exact
Comparison: Discharge: Patient able to sit up in bedp-value: 0.1189Chi-squared
Comparison: Discharge: Patient able to stand upp-value: 1Fisher Exact
Comparison: Discharge: Patient able to walkp-value: 0.6992Fisher Exact
Comparison: Discharge: Right Shoulder Flexion Movementp-value: 0.4429Fisher Exact
Comparison: Discharge: Left Shoulder Flexion Movementp-value: 0.4563Fisher Exact