Subscap Reverse Shoulder Arthroplasty

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05344898
Status
Recruiting
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Conditions

  • Rotator Cuff Injuries
  • Shoulder Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • Subscap Tenotomy — PROCEDURE
    Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.
  • Subscap Repair — PROCEDURE
    Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

Study Details

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.

Key Dates

Start date
Nov 15, 2022
Status verified
Jun 2025
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subscap Tenotomy
    The subscapularis tendon is not repaired.
  • Experimental: Subscap Repair
    The subscapularis tendon is repaired.

Primary Outcome Measure

Change in Internal Rotation [ Time Frame: Pre-op and post-op Months 3,6,12,24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland School of MedicineBaltimoreMaryland21201
Mohit N Gilotra, M.D./M.S.
[email protected]
3015024102
Kevin K Wendeu-Foyet, B.S
[email protected]
301-978-1431

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