Subscap Reverse Shoulder Arthroplasty

Study Overview
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Brief Summary
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The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

Official Title
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Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study

Conditions
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Shoulder Injuries, Rotator Cuff Injuries

Intervention / Treatment
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* Procedure: Subscap Tenotomy
* Procedure: Subscap Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 95 years old Undergoing reverse shoulder arthroplasty for any indication including revision surgery Exclusion Criteria: Irreparable Subscapularis Tendon a. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification. Any history of proximal humerus fracture Any revision with proximal humerus bone loss

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subscap Tenotomy<br> | Procedure: Subscap Tenotomy<br>* Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.<br>|
| Experimental: Subscap Repair<br> | Procedure: Subscap Repair<br>* Group will have their subscapularis tendon repaired following a reverse shoulder replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Internal Rotation | Internal rotation behind the back | Pre-op and post-op Months 3,6,12,24 | 
| Change in BOSS Scores | Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform. | Pre-op and post-op Months 3,6,12,24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ASES score | Change in American Shoulder and Elbow Surgeon (ASES) score over 2 years postoperatively compared to preoperative. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain possible. | Pre-op and post-op Months 3,6,12,24 |