Status:
RECRUITING
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Lake Health
Midwest Orthopaedics at Rush
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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 p...
Detailed Description
Rotator cuff injury is a commonly encountered problem within the United States. In most cases, surgical repair can reduce pain and restore baseline functional status. However, in the case of an irrepa...
Eligibility Criteria
Inclusion
- Age range: ≥18 years
- Irreparable rotator cuff tear suspected on pre-operative MRI
Exclusion
- Pregnant, illiterate, or non-English speaking individuals
- Rotator cuff pathology amenable to a complete repair intraoperatively
- Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
- Presence of glenohumeral arthritis on radiographs
- Irreparable subscapularis muscle intraoperatively
- Active infection within the ipsilateral glenohumeral joint
- Neurologic pathology limiting shoulder function
- Current smoker
- Workers' compensation claim
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04742452
Start Date
November 24 2020
End Date
January 1 2026
Last Update
December 10 2025
Active Locations (3)
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1
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
3
Lake Health
Willoughby, Ohio, United States, 44094