Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.

Detailed Description
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Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.

Official Title
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Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)

Conditions
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Arthroplasty, Replacement, Shoulder

Intervention / Treatment
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* Device: Regeneten
* Procedure: Standard repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients healthy enough to undergo primary anatomic TSA Being treated with subscapularis tenotomy or subscapularis peel. Age 50 or above Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available). Exclusion Criteria: Revision arthroplasty Reverse arthroplasty Requiring a lesser tuberosity osteotomy Intraoperative identification of rotator cuff tear requiring repair Object to using cow derived material Prior index shoulder surgery requiring treatment to the subscapularis

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regeneten<br>Standard subscapularis repair with Regeneten augmentation group | Device: Regeneten<br>* Augmentation of standard subscapularis repair with regeneten patch<br>|
| Other: Standard repair<br>Standard subscapularis repair | Procedure: Standard repair<br>* Standard subscapularis repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subscapularis repair integrity assessed by lift-off test using dynamometry. | Pounds (lbs) of force that the subject can produce during the lift off test will be recorded. | 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forward elevation active range of motion as assessed by treating physician | The amount of forward elevation range of motion will be reported in degrees from 0-180. | 6 weeks | 
| Forward elevation active range of motion as assessed by treating physician | The amount of forward elevation range of motion will be reported in degrees from 0-180. | 3 months | 
| Forward elevation active range of motion as assessed by treating physician | The amount of forward elevation range of motion will be reported in degrees from 0-180. | 6 months | 
| Forward elevation active range of motion as assessed by treating physician | The amount of forward elevation range of motion will be reported in degrees from 0-180. | 12 months | 
| Abduction active range of motion as assessed by treating physician | The amount of abduction range of motion will be reported in degrees from 0-180. | 6 weeks | 
| Abduction active range of motion as assessed by treating physician | The amount of abduction range of motion will be reported in degrees from 0-180. | 3 months | 
| Abduction active range of motion as assessed by treating physician | The amount of abduction range of motion will be reported in degrees from 0-180. | 6 months | 
| Abduction active range of motion as assessed by treating physician | The amount of abduction range of motion will be reported in degrees from 0-180. | 12 months | 
| External rotation active range of motion as assessed by treating physician | The amount of external rotation range of motion will be reported in degrees from 0-180. | 6 weeks | 
| External rotation active range of motion as assessed by treating physician | The amount of external rotation range of motion will be reported in degrees from 0-180. | 3 months | 
| External rotation active range of motion as assessed by treating physician | The amount of external rotation range of motion will be reported in degrees from 0-180. | 6 months | 
| External rotation active range of motion as assessed by treating physician | The amount of external rotation range of motion will be reported in degrees from 0-180. | 12 months | 
| Internal rotation active range of motion as assessed by treating physician | The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher. | 6 weeks | 
| Internal rotation active range of motion as assessed by treating physician | The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher. | 3 months | 
| Internal rotation active range of motion as assessed by treating physician | The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher. | 6 months | 
| Internal rotation active range of motion as assessed by treating physician | The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher. | 12 months | 
| Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES) | The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 6 weeks | 
| Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES) | The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 3 months | 
| Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES) | The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 6 months | 
| Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES) | The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 12 months | 
| Patient reported clinical outcome scores- Visual Analog Scale (VAS) | The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain. | 6 weeks | 
| Patient reported clinical outcome scores- Visual Analog Scale (VAS) | The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain. | 3 months | 
| Patient reported clinical outcome scores- Visual Analog Scale (VAS) | The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain. | 6 months | 
| Patient reported clinical outcome scores- Visual Analog Scale (VAS) | The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain. | 12 months | 
| Patient reported clinical outcome scores- Simple shoulder test (SST) | The simple shoulder test is a series of 12 yes or no questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function. | 6 weeks | 
| Patient reported clinical outcome scores- Simple shoulder test (SST) | The simple shoulder test is a series of 12 yes or no questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function. | 3 months | 
| Patient reported clinical outcome scores- Simple shoulder test (SST) | The simple shoulder test is a series of 12 yes or no questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function. | 6 months | 
| Patient reported clinical outcome scores- Simple shoulder test (SST) | The simple shoulder test is a series of 12 yes or no questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function. | 12 months | 
| Patient reported clinical outcome scores- Simple shoulder value (SST) | The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | 6 weeks | 
| Patient reported clinical outcome scores- Simple shoulder value (SST) | The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | 3 months | 
| Patient reported clinical outcome scores- Simple shoulder value (SST) | The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | 6 months | 
| Patient reported clinical outcome scores- Simple shoulder value (SST) | The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | 12 months |