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NCT05981833Recruiting

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Arthrex, Inc.

Start Date

9/25/2023

Completion Date

9/15/2026

Summary

The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).

Detailed Description

The primary objective is to evaluate postoperative healing of rotator cuff repair with and without DAA. Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) Secondary: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including: American Shoulder and Elbow Surgeons Score (ASES) Single Assessment Numeric Evaluation score (SANE) Visual Analog Scale (VAS) for pain Veterans RAND Health Survey (VR-12) Population: Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears Description of Treatment: Rotator cuff repair with or without augmentation using decellularized human dermal allograft.

Eligibility Criteria

Age Range: 30 years to 75 years

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

Interventions

DEVICE

Repair with DAA (dermal allograft augmentation)

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Conditions

Full-thickness Rotator Cuff Tear

Locations

University of Arizona, Banner Health

Scottsdale, Arizona 85006

United States

Orthopaedic & Nuerosurgery Specialists

Greenwich, Connecticut 06831

United States

Southern Oregon Orthopedics Research Foundation

Medford, Oregon 97504

United States

Tennessee Orthopedic Foundation for Research Education and Research

Nashville, Tennessee 37204

United States