Comparing two surgical techniques for massive rotator cuff tears
Official title: Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial
Run by Sunnybrook Health Sciences Centre · NCT03617562 · Data updated 2026-11-12
This study is testing whether a new surgical technique called superior capsular reconstruction works better than a partial rotator cuff repair for people with large, irreparable rotator cuff tears who haven't found relief from other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | July 18, 2018 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT03617562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with symptomatic massive rotator cuff tears greater than 4 cm who have failed at least three months of non-surgical treatment.
✕Probably not a fit
Patients with advanced rotator cuff tear arthropathy, acute tears, or significant medical comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the effectiveness of superior capsular reconstruction (SCR) versus partial rotator cuff repair (PRCR) in patients with massive irreparable rotator cuff tears. It is a randomized, controlled, double-blinded trial that will involve multiple centers and surgeons. The study will assess outcomes such as pain relief and functional improvement in patients who have not responded to non-surgical treatments. Randomization will occur intra-operatively once a tear is confirmed as irreparable, ensuring a rigorous comparison of the two surgical approaches.
Why it matters
Potential benefit: If successful, this study could provide evidence-based guidance for surgical treatment options in patients with massive rotator cuff tears.
How similar studies have gone: While SCR has shown promising results in early case series, this study is among the first to rigorously compare it with PRCR in a randomized controlled setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis) * Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus. * Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications * Irreparable tear determined intra-operatively using standard arthroscopic techniques * Informed consent obtained Exclusion Criteria: * Absence of subscapularis muscle insertion, or irreparable subscapularis tear * Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+) * Acute tears (within 6 months) * Neurologic injury causing paralysis of affected shoulder / arm * Any previous surgery to the affected shoulder * Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher) * Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.) * Are there any non-orthopedic comorbidities that put the patient at significant risk?
Where it's running
-
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, Canada Recruiting -
Women's College Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Patrick Henry, MD, FRCSC — Sunnybrook Health Sciences
- Study coordinator: Patrick Henry, MD, FRCSC
- Email: patrick.henry@sunnybrook.ca
- Phone: 416-967-8701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.