Comparing two surgical techniques for massive rotator cuff tears
Arthroscopic Assisted Lower Trapezius Tendon Transfer vs Bridging Repair for Irreparable Rotator Cuff Tears: A Randomized Controlled Trial
This study is testing which of two surgical methods works better for people with large, irreparable rotator cuff tears to see how they affect recovery and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05925881 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of two surgical techniques for treating massive irreparable rotator cuff tears: bridging reconstruction using an acellular human dermal allograft and lower trapezius tendon transfer. A total of 60 patients will be randomized into one of the two treatment groups and followed for a minimum of two years. The study will assess the maintenance of acromiohumeral distance, strength, range of motion, and patient-reported quality of life scores. Pre-operative evaluations will include MRI and structured clinical examinations.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with MRI-proven massive rotator cuff tears larger than 5cm and less than 50% muscle atrophy.
Not a fit: Patients with irreparable subscapular tears, glenohumeral osteoarthritis, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for improving outcomes in patients with massive rotator cuff tears.
How similar studies have performed: While there is ongoing research in this area, the specific comparison of these two techniques has not been extensively tested, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear * tear size \>5cm * two-tendon, irreparable tear * competent adult (\>18 years of age) * \<50% muscle atrophy. Exclusion Criteria: * irreparable subscapular tear * glenohumeral osteoarthritis * WORC score \> 70 * uncontrolled diabetes (Hgb A1C \>7%) * pregnancy * presence of local or systemic infection * inability to cooperate with and/or comprehend post-operative instructions * cancer * paralysis of the shoulder * contracture of the shoulder * inability to provide informed consent
Where this trial is running
Halifax, Nova Scotia
- 5955 Veterans' Memorial Lane Room 2106, VMB — Halifax, Nova Scotia, Canada (Recruiting)
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.