Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Start Date
7/28/2023
Completion Date
8/1/2027
Summary
Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Rotator cuff repairs with BioEnthesis augmentation
Rotator cuff repairs without BioEnthesis augmentation
Conditions
Locations
10th Medical Group - Air Force Academy
Air Force Academy, Colorado 80840
United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina 27514
United States
Duke University
Durham, North Carolina 27710
United States
Brooke Army Medical Center
San Antonio, Texas 78234
United States