Arthrex, Inc.
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).
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 ag…
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…
Patients undergo rotator cuff repair with dermal allograft augmentation.
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