Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Trial Parameters
Brief 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).
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