RecruitingNot ApplicableNCT05344898

Subscap Reverse Shoulder Arthroplasty

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


Sponsor

University of Maryland, Baltimore

Enrollment

118 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study compares different surgical techniques for reattaching the subscapularis tendon during reverse shoulder replacement (arthroplasty). The subscapularis is a key shoulder muscle, and how well it heals after surgery may affect long-term function. You may be eligible if... - You are between 18 and 95 years old - You are undergoing reverse shoulder arthroplasty for any reason, including a revision procedure - Your subscapularis tendon is intact and repairable (confirmed by MRI or CT scan) You may NOT be eligible if... - Your subscapularis tendon is irreparable (significant fatty degeneration or Grade II fatty infiltration or worse per Goutallier classification) - You have a prior history of proximal humerus (upper arm bone) fracture - You are having a revision surgery that involves significant bone loss in the proximal humerus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESubscap Tenotomy

Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.

PROCEDURESubscap Repair

Group will have their subscapularis tendon repaired following a reverse shoulder replacement.


Locations(1)

University of Maryland School of Medicine

Baltimore, Maryland, United States

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NCT05344898


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