Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial
Sunnybrook Health Sciences Centre
70 participants
Jul 18, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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?
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Interventions
Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.
Rotator cuff is repaired with residual defect remaining.
Locations(2)
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NCT03617562