Recruiting

Rotator Cuff Repair

Sponsor:

University of Maryland, Baltimore

Code:

NCT05344898

Conditions

Shoulder Injuries

Rotator Cuff Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Subscap Tenotomy

Subscap Repair

Study Details

Brief 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.

Conditions

Shoulder Injuries

Rotator Cuff Injuries

Study ID

NCT05344898

Start date

Nov 15, 2022

Status verified date

Jul, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18 to 95 years old
2. Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion Criteria:

1. Irreparable Subscapularis Tendon

a. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification.
2. Any history of proximal humerus fracture
3. Any revision with proximal humerus bone loss

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subscap Tenotomy

The subscapularis tendon is not repaired.

experimental: Subscap Repair

The subscapularis tendon is repaired.

Interventions

Subscap Tenotomy

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

Subscap Repair

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Mohit N Gilotra, M.D./M.S.

3015024102MGilotra@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-10.