Actively Recruiting
Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
Led by Sunnybrook Health Sciences Centre · Updated on 2024-09-19
70
Participants Needed
2
Research Sites
519 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
W
Women's College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic shoulder pain and/or weakness regardless of baseline motion
- Massive rotator cuff tear over 4 cm involving supraspinatus and infraspinatus confirmed by MRI
- Failure of at least 3 months of non-surgical treatment including physiotherapy and activity modifications
- Irreparable tear confirmed during surgery using standard arthroscopic techniques
- Informed consent obtained
You will not qualify if you...
- Absence or irreparable tear of the subscapularis muscle
- Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or moderate to severe glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
- Acute tears occurring within the past 6 months
- Neurologic injury causing paralysis of the affected shoulder or arm
- Previous surgery on the affected shoulder
- Limited life expectancy due to serious medical conditions or contraindications to surgery (ASA Grade IV or higher)
- Expected difficulty maintaining follow-up (e.g., no fixed address)
- Significant non-orthopedic medical conditions that increase risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, Canada, M4Y 1H1
Actively Recruiting
2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
Research Team
P
Patrick Henry, MD, FRCSC
CONTACT
R
Ryan A Paul, MD, FRCSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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