Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
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
Interventions
Repair with DAA (dermal allograft augmentation)
Conditions
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