Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.

Official Title
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Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial

Conditions
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Shoulder Osteoarthritis, Arthropathy Shoulder

Intervention / Treatment
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* Procedure: Subscapularis repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary RSA procedure with repairable (intact) SSc Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant Diagnosis with imaging of arthropathy with rotator cuff insufficiency Surgical approach: Deltopectoral Fluent English speakers/readers Exclusion Criteria: Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent) Revision surgery Oncologic surgery non-ZB CRSS implants Unrepairable SSc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subscapularis repair<br>Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair | Procedure: Subscapularis repair<br>* To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.<br>|
| No Intervention: No repair<br>Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The American Shoulder and Elbow Surgeons (ASES) Shoulder Score | Scored from 0 (worst shoulder condition) to 100 (best shoulder condition) | up to 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal Rotator (IR) Strength | IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side | up to 12 months post-surgery | 
| PROMIS Bank v1.1 - Pain Interference | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). | up to 12 months post-surgery | 
| Shoulder Range of Motion | shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side | up to 12 months post-surgery |