Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

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.

NCT Number	NCT06289686
Lead Sponsor	Brooke Army Medical Center Collaborators: Sparta Biopharma
Conditions	Rotator Cuff Tears, Rotator Cuff Injuries, Surgery
Enrollment	100 participants
Start Date	2023-07-28
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-13