Massive tears of the rotator cuff.
Asheesh Bedi, Joshua Dines, Russell F Warren...
https://pubmed.ncbi.nlm.nih.gov/20686065Actively Recruiting
Led by University Hospitals Cleveland Medical Center · Updated on 2026-02-12
105
Participants Needed
3
Research Sites
N/A
Total Duration
U
University Hospitals Cleveland Medical Center
Lead Sponsor
L
Lake Health
Collaborating Sponsor
This research aims to compare two surgical treatments for patients with irreparable rotator cuff tears, a challenging shoulder injury. The study evaluates pain and functional outcomes using several measures including the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and PROMIS-29 score at multiple time points up to 24 months after surgery. It also investigates the failure rates of the treatments using MRI scans at 12 months post-operation. The goal is to understand if adding superior capsular reconstruction (SCR) to partial rotator cuff repair provides any benefit over partial repair alone. Participants will be randomly assigned to one of two groups: one receiving partial rotator cuff repair alone, and the other receiving partial rotator cuff repair combined with superior capsular reconstruction using acellular dermal allograft. Both surgeries may include other procedures such as subacromial decompression and biceps tenodesis. Surgery will be performed after medical clearance, and intraoperative data such as repair techniques and any complications will be recorded. Patients will follow an identical post-operative care plan and medication regimen. Throughout the study, participants will attend follow-up visits at 6 weeks, 3, 6, 12, and 24 months after surgery. At each visit, pain and shoulder function will be assessed using the VAS, SST, ASES, and PROMIS-29 questionnaires, and any complications will be noted. An MRI will be performed at 12 months to assess repair integrity. Researchers will collect data including demographics, injury details, and surgical outcomes to evaluate differences between the two surgical approaches over the two-year period.
CONDITIONS
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery to receive either a partial rotator cuff repair alone or a partial rotator cuff repair with superior capsular reconstruction. Intraoperative data and any complications are recorded.
1 surgical visit (in-person)
Duration - 24 months
Participants attend scheduled clinic visits for up to 24 months after surgery to assess pain, function, complications, and repair integrity. Surveys and imaging are performed at specified visits.
5 visits at 6 weeks, 3, 6, 12, and 24 months (in-person)
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
J
John T Strony, BS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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