Comparing two surgical techniques for massive rotator cuff tears

Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT03617562 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with advanced rotator cuff tear arthropathy, acute tears, or significant medical comorbidities may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Toronto, Ontario and 1 other locations

• 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

Conditions: Rotator Cuff Tear, Massive Rotator Cuff Tear, Shoulder Injuries