An interventional study of Superior Capsular Reconstruction and Partial Repair in Rotator Cuff Tear, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
The current study seeks to improve the management of patients suffering from massive irreparable rotator cuff tears. Despite several available surgical options, no level 1 evidence or randomized clinical trials have been performed in this patient population to date. Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique of superior capsular reconstruction (SCR) has also emerged with early biomechanical and case series showing promising results. SCR has quickly made its way into clinical practice in North America. Despite this, the effectiveness, cost, and safety profile has not been established for this procedure. As such, patients with massive irreparable rotator cuff tears are in need of high level evidence to support surgical decision making, particular with regards to the proliferation of SCR surgery.
This pilot study is a randomized, controlled, double-blinded trial comparing superior capsular reconstruction using dermal allograft with arthroscopic partial repair in patients with massive irreparable rotator cuff tears. In this study, "double-blind" includes study patients and outcome assessors. Randomization will occur intra-operatively once a tear is determined to be irreparable.
This trial will be conducted at 7 sites and involve 7 surgeons. Surgeons must meet eligibility requirements to participate (shoulder or sports fellowship-trained, minimum of 3 SCR procedures, and 25 arthroscopic rotator cuff repair procedures in the past year). A member of the local research team will pre-screen consults of eligible patients. Full eligibility will be determined during the primary appointment with an orthopaedic surgeon. Baseline data will be recorded following informed consent. Postoperative outcomes will be measured during regularly scheduled clinic visits (6 weeks, 3 months, 6 months, 1-year and 2-year post-surgery).
Prior to surgery, patients will have informed consent for both procedures, with randomization to be performed intraoperatively. Based on initial arthroscopic assessment of the shoulder, patients that have a confirmed irreparable tear will be randomized into one of two groups: arthroscopic partial repair or superior capsular reconstruction. Surgical techniques will be standardized. Allocation will be concealed using a centralized 24-hour computerized randomization system that will allow Internet-based allocation. A random number generator will be used to create a 1:1 allocation scheme for randomization of the patient into one of the two treatment groups. The post-operative therapy regimen will be the same for each group.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft.
Procedure: Superior Capsular Reconstruction
Patients will have a partial repair with residual defect as an established standard procedure.
Procedure: Partial Repair
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.
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)
Time frame: 1 year post operative
Complication rate
Incidence of minor and major complications related to each procedure.
Time frame: 1 year post operative
Recruitment rate
Assessment of number of eligible patients identified and number enrolled and randomized.
Time frame: 1 year post operative
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.
Time frame: 1 year post operative
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.
Time frame: 1 year post operative
Pain: Numeric Rating Scale
Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.
Time frame: 1 year post operative
Range of Motion
Measured by handheld goniometer
Time frame: 1 year post operative
EQ-5D
Health Related Quality of Life The EQ-5D questionnaire is made up for two components; health state description and evaluation. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. Visual analogue scale: 20 cm vertical scale with end points of 0 and 100. 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".
Time frame: 1 year post operative
Xray: Acromio-Humeral Interval
Measured distance from inferior acromion to superior humeral head at the closest distance. Distance in millimetres.
Time frame: 1 year post operative
Xray: Degenerative Change
Measured by Samilson-Prieto Grade: Mild Arthritis (Grade 1): inferior humeral and/or glenoid exostosis \< 3mm in height Moderate Arthritis (Grade 2): inferior humeral and/or glenoid exostosis measuring 3mm to 7mm slight gleno-humeral irregularity Severe Arthritis (Grade 3): inferior humeral and/or glenoid exostosis measuring \> 7mm gleno-humeral joint narrowing and sclerosis
Time frame: 1 year post operative
MRI - graft healing
Assess graft integrity: Healed or Torn
Time frame: 1 year post operative
MRI - tear size
Assess size of recurrent tear (in maximum anterior to posterior and medial to lateral dimensions). Measured in cm.
Time frame: 1 year post operative
MRI - fatty degeneration
Measured by Goutallier classification of each rotator cuff muscle: grade 0: normal muscle grade 1: some fatty streaks grade 2: less than 50% fatty muscle atrophy grade 3: 50% fatty muscle atrophy grade 4: greater than 50% fatty muscle atrophy
Time frame: 1 year post operative
Plan to share: No
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