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.
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
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
Parallel
Superior Capsular Reconstruction
Procedure/SurgeryResidual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.
Partial Repair
Procedure/SurgeryRotator cuff is repaired with residual defect remaining.
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Functional Outcome Score Sub scales: Pain (10 cm VAS); function/disability (10 items, each rated on 4-point Likert scale for level of difficulty) Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
Complication rate
Incidence of minor and major complications related to each procedure.
Recruitment rate
Assessment of number of eligible patients identified and number enrolled and randomized.
Constant-Murley Score
Functional outcome score Sub scales: Pain item (4 Likert levels), Activities of Daily Living (Likert scales), Mobility (2 points for every 30 degrees of elevation), Strength (1 point per 0.5 kg) Score Range: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). Total score: 0-100. The higher the score, the higher the quality of the function.
Western Ontario Rotator Cuff Index
Functional outcome score Consists of 21 visual analog scale (VAS) items organised in 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions. Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
Women's College Hospital
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
The Ottawa Hospital
Collaborator
