Comparing rotator cuff repair with and without dermal allograft augmentation

A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

This study is testing whether using a special tissue graft during rotator cuff surgery helps people aged 30 to 75 with large tears and fatty muscle changes heal better than surgery without the graft.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 30 Years to 75 Years
• Sex: All
• Sponsor: Arthrex, Inc. (Industry-sponsored)
• Locations: 4 sites (Scottsdale, Arizona and 3 other locations)
• Trial ID: NCT05981833 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the healing outcomes of large and massive rotator cuff tears repaired with or without the use of dermal allograft augmentation. It focuses on patients aged 30 to 75 who have confirmed fatty infiltration of the rotator cuff muscles. The primary outcome will be assessed through postoperative MRI evaluations, while secondary outcomes will include various patient-reported measures of shoulder function and pain. The study will involve multiple locations across the United States.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 30 to 75 requiring surgery for large or massive rotator cuff tears with significant fatty infiltration.

Not a fit: Patients with lower stages of fatty infiltration or those with specific exclusions such as certain types of subscapularis tears may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance healing and recovery for patients with severe rotator cuff injuries.

How similar studies have performed: While the use of dermal allografts in rotator cuff repairs is being explored, this specific approach and its outcomes are relatively novel.

Eligibility criteria

Inclusion Criteria:

* The subject is between the ages of 30 and 75 years.
* Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
* Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension
* Primary rotator cuff repair
* Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder

Exclusion Criteria:

* The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.
* The subject objects to the use of allograft
* Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle
* Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)
* Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
* Recurrent shoulder instability
* Corticosteroid injection in the operative shoulder within one month of surgery
* Revision rotator cuff repair
* Subject preoperative MRI obtained more than 12 months prior to surgery
* Pregnant or planning to become pregnant during the study period
* Workman's compensation case
* Subject has conditions or circumstances that would interfere with study requirements.

Intraoperative exclusion criteria:

Partial rotator cuff repairs

Lafosse grade 3 or higher subscapularis tears

Where this trial is running

Scottsdale, Arizona and 3 other locations

• University of Arizona, Banner Health — Scottsdale, Arizona, United States (Recruiting)
• Orthopaedic & Nuerosurgery Specialists — Greenwich, Connecticut, United States (Recruiting)
• Southern Oregon Orthopedics Research Foundation — Medford, Oregon, United States (Recruiting)
• Tennessee Orthopedic Foundation for Research Education and Research — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Caroline Caraci, BA

Conditions Full-thickness Rotator Cuff Tear