Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Recruiting now

Conditions studied: Full-thickness Rotator Cuff Tear

In brief

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).

Key facts

Study ID

NCT05981833

Run by

Arthrex, Inc.

People needed

120

Starts

2023-09-25

Expected to finish

2026-09-15

Last updated by the study team

2025-02-24

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona, Banner Health — Scottsdale, Arizona, United States (enrolling)
• Orthopaedic & Nuerosurgery Specialists — Greenwich, Connecticut, United States (enrolling)
• Southern Oregon Orthopedics Research Foundation — Medford, Oregon, United States (enrolling)
• Tennessee Orthopedic Foundation for Research Education and Research — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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