Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
Healthy Volunteers
NCT04742452

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

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Suspected irreparable rotator cuff tear on pre-operative MRI
Not Eligible

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

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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

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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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