Status:
RECRUITING
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Lead Sponsor:
Arthrex, Inc.
Conditions:
Full-thickness Rotator Cuff Tear
Eligibility:
All Genders
30-75 years
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 de...
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 Assessme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05981833
Start Date
September 25 2023
End Date
September 15 2026
Last Update
February 24 2025
Active Locations (4)
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1
University of Arizona, Banner Health
Scottsdale, Arizona, United States, 85006
2
Orthopaedic & Nuerosurgery Specialists
Greenwich, Connecticut, United States, 06831
3
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States, 97504
4
Tennessee Orthopedic Foundation for Research Education and Research
Nashville, Tennessee, United States, 37204