About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Superior Capsular Reconstruction
- Partial Repair
Treatment groups
Sponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
Women's College Hospital
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
The Ottawa Hospital
Collaborator