Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

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.

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