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Clinical Trials in Canada / NCT03617562
Recruiting Not applicable

Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears

NCT03617562 · tracked via the Priya Life Science Canada tracker
Sponsor
Sunnybrook Health Sciences Centre
Phase
Not applicable
Started
2018-07-18
Last updated
2026-07-30

Condition(s) studied

Rotator Cuff Tear

Investigational drug(s) / intervention(s)

Superior Capsular ReconstructionPartial Repair

Superior Capsular Reconstruction: Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.

Partial Repair: Rotator cuff is repaired with residual defect remaining.

Study summary

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.

The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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?

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sunnybrook Holland Orthopaedic & Arthritic Centre Toronto Ontario Recruiting
Women's College Hospital Toronto Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03617562 on ClinicalTrials.gov ↗ ← All trials in Canada