Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
Healthy Volunteers
ID04742452

Comparison of Partial Rotator Cuff Repair versus 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

N/A

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

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

Brief 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 based on pre-operative MRI
Not Eligible

You will not qualify if you...

  • Pregnant individuals
  • Illiterate or non-English speaking
  • Rotator cuff tear amenable to complete repair during surgery
  • Moderate to severe rotator cuff arthropathy (Hamada grade 3 or higher)
  • Glenohumeral arthritis seen on X-rays
  • Irreparable subscapularis muscle during surgery
  • Active infection in the affected shoulder joint
  • Neurologic conditions limiting shoulder function
  • Current smokers
  • Workers' compensation claim

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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)

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

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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Published Research Related To This Trial

Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases.

Gilles Walch, T Bradley Edwards, Aziz Boulahia...

https://pubmed.ncbi.nlm.nih.gov/15889020