Actively Recruiting
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
Led by University Hospitals Cleveland Medical Center · Updated on 2026-02-12
105
Participants Needed
3
Research Sites
287 weeks
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
L
Lake Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.
CONDITIONS
Official Title
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Suspected irreparable rotator cuff tear on pre-operative MRI
You will not qualify if you...
- Pregnant, illiterate, or non-English speaking individuals
- Rotator cuff tear that can be completely repaired during surgery
- Moderate to severe rotator cuff arthropathy (Hamada grade 3 or higher)
- Glenohumeral arthritis seen on X-rays
- Irreparable subscapularis muscle found during surgery
- Active infection in the shoulder joint on the same side
- Neurologic conditions affecting shoulder function
- Current smoker
- Workers' compensation claim
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
Not Yet Recruiting
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
3
Lake Health
Willoughby, Ohio, United States, 44094
Actively Recruiting
Research Team
J
John T Strony, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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