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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoanalgesia + Standard of Care (SOC) | Experimental | Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoanalgesia | Device | AtriCure® cryoICE cryo-ablation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48-hours post-surgery |
| 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. | 48-hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Lau, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California (USC) | Los Angeles | California | 90033 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23424242 | Background | Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19. | |
| 11509270 | Background | Moorjani N, Zhao F, Tian Y, Liang C, Kaluba J, Maiwand MO. Effects of cryoanalgesia on post-thoracotomy pain and on the structure of intercostal nerves: a human prospective randomized trial and a histological study. Eur J Cardiothorac Surg. 2001 Sep;20(3):502-7. doi: 10.1016/s1010-7940(01)00815-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Liters (L) | 48-hours post-surgery |
|
Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit.
The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoanalgesia + 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Breast Pain/Numbness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nfii Ndikitum | AtriCure | 513-644-8192 | nndikintum@atricure.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2016 | May 12, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2016 | Jul 1, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Drug | Institutional SOC for pain management will be followed. |
|
|
| 48-hours post-extubation |
| 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. | 72-, 96- and 120-hours Post-Op |
| 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. | 3 and 6 Months |
| 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. | Hours until patient is extubated from time patient leaves the operating room |
| 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. | 24-, 48, -96 and 120-hours |
| 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. | Procedure to Discharge |
| 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. | Baseline, 48, 72, 96, 120 Hours and Discharge |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| United Heart and Vascular Institute - Allina | Saint Paul | Minnesota | 55102 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| 24415737 | Background | Glauber M, Karimov JH, Farneti PA, Cerillo AG, Santarelli F, Ferrarini M, Del Sarto P, Murzi M, Solinas M. Minimally invasive mitral valve surgery via right minithoracotomy. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(122):mmcts.2008.003350. doi: 10.1510/mmcts.2008.003350. |
| 4859864 | Background | Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available. |
| 14950594 | Background | PAPPER EM, BRODIE BB, ROVENSTINE EA. Postoperative pain; its use in the comparative evaluation of analgesics. Surgery. 1952 Jul;32(1):107-9. No abstract available. |
| 2764599 | Background | Katz J. Cryoanalgesia for postthoracotomy pain. Ann Thorac Surg. 1989 Jul;48(1):5. doi: 10.1016/0003-4975(89)90166-5. No abstract available. |
| 9352765 | Background | Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4. |
| 13913200 | Background | SIMPSON BR, PARKHOUSE J, MARSHALL R, LAMBRECHTS W. Extradural analgesia and the prevention of postoperative respiratory complications. Br J Anaesth. 1961 Dec;33:628-41. doi: 10.1093/bja/33.12.628. No abstract available. |
| 3736085 | Background | Maiwand MO, Makey AR, Rees A. Cryoanalgesia after thoracotomy. Improvement of technique and review of 600 cases. J Thorac Cardiovasc Surg. 1986 Aug;92(2):291-5. |
| 3255292 | Background | Gough JD, Williams AB, Vaughan RS, Khalil JF, Butchart EG. The control of post-thoracotomy pain. A comparative evaluation of thoracic epidural fentanyl infusions and cryo-analgesia. Anaesthesia. 1988 Sep;43(9):780-3. doi: 10.1111/j.1365-2044.1988.tb05757.x. |
| 14966345 | Background | Gwak MS, Yang M, Hahm TS, Cho HS, Cho CH, Song JG. Effect of cryoanalgesia combined with intravenous continuous analgesia in thoracotomy patients. J Korean Med Sci. 2004 Feb;19(1):74-8. doi: 10.3346/jkms.2004.19.1.74. |
| 34545530 | Derived | Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20. |
| Physician Decision |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Forced Expiratory Value (FEV1) | Mean | Standard Deviation | Liters (L) |
|
| Visual Analog Scale (general) | 0-10 Numeric Pain Rating Scale | Mean | Standard Deviation | units on a scale |
|
| Visual Analog Scale (surgical site) | 0-10 Numeric Pain Rating Scale at the surgical site. | Mean | Standard Deviation | units on a scale |
|
| Society of Thoracic Surgeon Score (STS) | Risk of Mortality Percentage - High is greater than or equal to 8%, intermediate is greater than or equal to 4% and low is less than 4%. | The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants. | Mean | Standard Deviation | Percentage |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 48-hours post-surgery |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Liters (L) | 48-hours post-extubation |
|
|
|
|
| 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. | Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay. | Posted | Mean | Standard Deviation | units on a scale | 72-, 96- and 120-hours Post-Op |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 and 6 Months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Hours | Hours until patient is extubated from time patient leaves the operating room |
|
|
|
|
| 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. | Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalent (MME) | 24-, 48, -96 and 120-hours |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Days | Procedure to Discharge |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 48, 72, 96, 120 Hours and Discharge |
|
|
|
|
| 8 |
| 65 |
| 0 |
| 65 |
| 2 |
| 65 |
| EG001 | 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. | 1 | 19 | 0 | 19 | 0 | 19 |
| Hyperesthesia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.518 |
| 2-Sided |
| 95 |
| Superiority |
| SVC |
|
FVC one-sided, two-sample t-test |
| Superiority |
| t-test, 1 sided | 0.09 | SVC one-sided, two-sample t-test | Superiority |
| 96 Hours Post-Op |
|
|
| 120 Hours Post-Op |
|
|
Wilcoxon rank-sum test.
| 0.8196 |
96 Hours Post-Op |
| Superiority |
| Wilcoxon (Mann-Whitney) | Wilcoxon rank-sum test. | 0.7269 | 120 Hours Post-Op | Superiority |
| 48 Hours |
|
|
| 96 Hours |
|
|
| 120 Hours |
|
|
| Total Post-Procedure for Hospital Stay |
|
|
Wilcoxon rank-sum test
| 0.0998 |
Hospital Length of Stay |
| Superiority |
| Yes - with assistance |
|
| No |
|
| Baseline - Able to stand up |
|
|
| Baseline - Able to walk |
|
|
| Baseline - Right shoulder flexion movement |
|
|
| Baseline - Left shoulder flexion movement |
|
|
| 48 Hours - Able to sit up in bed |
|
|
| 48 Hours - Able to stand up |
|
|
| 48 Hours - Able to walk |
|
|
| 48 Hours - Right shoulder flexion movement |
|
|
| 48 Hours - Left shoulder flexion movement |
|
|
| 72 Hours - Able to sit up in bed |
|
|
| 72 Hours - Able to stand up |
|
|
| 72 Hours - Able to walk |
|
|
| 72 Hours - Right shoulder flexion movement |
|
|
| 72 Hours - Left shoulder flexion movement |
|
|
| 96 Hours - Able to sit up in bed |
|
|
| 96 Hours - Able to stand up |
|
|
| 96 Hours - Able to walk |
|
|
| 96 Hours - Right shoulder flexion movement |
|
|
| 96 Hours - Left shoulder flexion movement |
|
|
| 120 Hours - Able to sit up in bed |
|
|
| 120 Hours - Able to stand up |
|
|
| 120 Hours - Able to walk |
|
|
| 120 Hours - Right shoulder flexion movement |
|
|
| 120 Hours - Left shoulder flexion movement |
|
|
| Discharge - Able to sit up in bed |
|
|
| Discharge - Able to stand up |
|
|
| Discharge - Able to walk |
|
|
| Discharge - Right shoulder flexion movement |
|
|
| Discharge - Left shoulder flexion movement |
|
|
| 0.5311 |
| Superiority |
| 48 Hours Post-Op: Patient able to walk | Fisher Exact | 0.4908 | Superiority |
| 48 Hours Post-Op: Right Shoulder Flexion Movement | Fisher Exact | 0.8621 | Superiority |
| 48 Hours Post-Op: Left Shoulder Flexion Movement | Fisher Exact | 1 | Superiority |
| 72 Hours Post-Op: Patient able to sit up in bed | Fisher Exact | 0.0133 | Superiority |
| 72 Hours Post-Op: Patient able to stand up | Fisher Exact | 0.0037 | Superiority |
| 72 Hours Post-Op: Patient able to walk | Fisher Exact | 0.1671 | Superiority |
| 72 Hours Post-Op: Right Shoulder Flexion Movement | Fisher Exact | 1.000 | Superiority |
| 72 Hours Post-Op: Left Shoulder Flexion Movement | Fisher Exact | 1 | Superiority |
| 96 Hours Post-Op: Patient able to sit up in bed | Fisher Exact | 1 | Superiority |
| 96 Hours Post-Op: Patient able to stand up | Fisher Exact | 0.2757 | Superiority |
| 96 Hours Post-Op: Patient able to walk | Fisher Exact | 0.9025 | Superiority |
| 96 Hours Post-Op: Right Shoulder Flexion Movement | Fisher Exact | 0.7942 | Superiority |
| 96 Hours Post-Op: Left Shoulder Flexion Movement | Fisher Exact | 1 | Superiority |
| 120 Hours Post-Op: Patient able to sit up in bed | Fisher Exact | 0.3492 | Superiority |
| 120 Hours Post-Op: Patient able to stand up | Fisher Exact | 0.2644 | Superiority |
| 120 Hours Post-Op: Patient able to walk | Fisher Exact | 0.8258 | Superiority |
| 120 Hours Post-Op: Right Shoulder Flexion Movement | Fisher Exact | 0.67 | Superiority |
| 120 Hours Post-Op: Left Shoulder Flexion Movement | Fisher Exact | 0.5693 | Superiority |
| Discharge: Patient able to sit up in bed | Chi-squared | 0.1189 | Superiority |
| Discharge: Patient able to stand up | Fisher Exact | 1 | Superiority |
| Discharge: Patient able to walk | Fisher Exact | 0.6992 | Superiority |
| Discharge: Right Shoulder Flexion Movement | Fisher Exact | 0.4429 | Superiority |
| Discharge: Left Shoulder Flexion Movement | Fisher Exact | 0.4563 | Superiority |