Actively Recruiting
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Led by Arthrex, Inc. · Updated on 2025-02-24
120
Participants Needed
4
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 75 years
- Planning arthroscopic surgery for full-thickness rotator cuff tear
- Two complete rotator cuff tears or tear size 3 cm or larger in anterior-posterior or medial-lateral dimension
- Primary rotator cuff repair
- Stage II or higher fatty infiltration of supraspinatus or infraspinatus muscle confirmed by preoperative MRI
- Has dual x-ray absorptiometry or anterior posterior x-ray view of target shoulder
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Objects to use of allograft
- Stage I or lower fatty infiltration of supraspinatus and infraspinatus muscles
- Complete full-thickness subscapularis tears greater than superior one third of tendon (Lafosse grade 3+)
- Glenohumeral joint space less than 2 mm on radiograph
- Recurrent shoulder instability
- Corticosteroid injection in operative shoulder within 1 month before surgery
- Revision rotator cuff repair
- Preoperative MRI older than 12 months before surgery
- Pregnant or planning pregnancy during study
- Workman's compensation case
- Conditions interfering with study requirements
- Partial rotator cuff repairs intraoperatively
- Lafosse grade 3 or higher subscapularis tears intraoperatively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Arizona, Banner Health
Scottsdale, Arizona, United States, 85006
Actively Recruiting
2
Orthopaedic & Nuerosurgery Specialists
Greenwich, Connecticut, United States, 06831
Actively Recruiting
3
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States, 97504
Actively Recruiting
4
Tennessee Orthopedic Foundation for Research Education and Research
Nashville, Tennessee, United States, 37204
Actively Recruiting
Research Team
C
Caroline Caraci, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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