Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears

Completed · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT04742452

Run by

University Hospitals Cleveland Medical Center

People needed

41

Starts

2020-11-24

Expected to finish

2026-04-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age range: ≥18 years
• Irreparable rotator cuff tear suspected on pre-operative MRI

You may not qualify if…

• 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

Where it is running

• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Lake Health — Willoughby, Ohio, United States

Full record on ClinicalTrials.gov

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