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RECRUITING
NCT05344898
NA

Subscap Reverse Shoulder Arthroplasty

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2022-11-15

Completion Date

2027-05-15

Last Updated

2025-06-25

Healthy Volunteers

Yes

Interventions

PROCEDURE

Subscap Tenotomy

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

PROCEDURE

Subscap 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