Comparing tendon repair options during reverse shoulder replacement
Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study
NA · University of Maryland, Baltimore · NCT05344898
This study tests whether repairing a specific shoulder tendon during reverse shoulder replacement can help patients move their arm better and reduce the chance of dislocation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05344898 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of repairing the subscapularis tendon versus not repairing it during reverse shoulder arthroplasty. The research aims to determine if tendon repair can reduce the risk of dislocation and improve arm movement after surgery. A total of 148 patients will be enrolled, and they will be randomly assigned to either the repair or no repair group. The study will track functionality and complications over a duration of five years to provide insights into the best surgical approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 95 who are scheduled for reverse shoulder arthroplasty.
Not a fit: Patients with irreparable subscapularis tendons or a history of proximal humerus fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing reverse shoulder replacement.
How similar studies have performed: While there is ongoing debate regarding tendon repair in shoulder surgeries, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- University of Maryland School of Medicine — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Mohit Gilotra, MD — University of Maryland, Baltimore
- Study coordinator: Mohit Gilotra, MD
- Email: mgilotra@som.umaryland.edu
- Phone: 3015024102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Injuries, Rotator Cuff Injuries