Using tendon transfers to repair massive rotator cuff tears
Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial
This study is testing which of two surgical techniques for repairing large rotator cuff tears helps people feel better and recover more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04588506 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different tendon transfer techniques to repair massive tears of the rotator cuff muscles in the shoulder. It involves a prospective randomized design with 84 participants, comparing outcomes between the Latissimus dorsi and Lower trapezius tendon transfer techniques. The study aims to determine which technique yields better patient-reported outcomes for individuals with irreparable rotator cuff tears. Participants will be randomly assigned to one of the two intervention groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with massive, irreparable posterior-superior rotator cuff tears and minimal glenohumeral arthritis.
Not a fit: Patients with severe glenohumeral arthritis, prior tendon transfers, or specific shoulder conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective surgical technique for repairing massive rotator cuff tears, potentially improving patient recovery and outcomes.
How similar studies have performed: There are currently no studies that have definitively shown which tendon transfer technique is superior for this condition, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must have massive, irreparable tear of the posterior-superior rotator cuff * Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age). * Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2 * Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY) Exclusion Criteria: * Subjects having severe glenohumeral arthritis * History of prior tendon transfer * Axillary nerve injury * Deltoid deficiency * Subjects with pseudo paralysis * History of post-operative deep shoulder infection * Non-English-speaking subjects. * Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study * Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)
Where this trial is running
Baltimore, Maryland
- U of Maryland Baltimore — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ashfaq S Hasan, MD — U of Maryland Baltimore
- Study coordinator: Ashfaq S Hasan, MD
- Email: ahassan@som.umaryland.edu
- Phone: 410-402-0640
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.