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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: t
View:

• 18 to 95 years old

• Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Locations
United States
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Mohit Gilotra, MD
mgilotra@som.umaryland.edu
3015024102
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 118
Treatments
Experimental: Subscap Tenotomy
The subscapularis tendon is not repaired.
Experimental: Subscap Repair
The subscapularis tendon is repaired.
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov