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Participating sites failed to secure funding and study was not feasible at one site.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subscapularis repair | Experimental | Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair |
|
| No repair | No Intervention | Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subscapularis repair | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Internal Rotator (IR) Strength | IR at the side and supported IR at 90Ëš 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Marra, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola Medicine | Maywood | Illinois | 60153 | United States | ||
| Beaumont Health |
There is no participant data to share. No participants were enrolled.
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| 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 |
| Royal Oak |
| Michigan |
| 48073 |
| United States |