Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation (NCT06289686)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: 10th Medical Group - Air Force Academy — Air Force Academy, Colorado
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
- Rotator cuff repairs with BioEnthesis augmentation (PROCEDURE)
- Rotator cuff repairs without BioEnthesis augmentation (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- 10th Medical Group - Air Force Academy — Air Force Academy, Colorado
- Walter Reed National Military Medical Center — Bethesda, Maryland
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina
- Duke University — Durham, North Carolina
- Brooke Army Medical Center — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (210) 916-2048
Email: David.J.Tennent.mil@health.mil
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rotator Cuff Tears
- E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults — New York, New York
- Variation in Humeral Head Bone Marrow Characteristics With Rotator Cuff Repair Healing — Cleveland, Ohio
- Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease — Great Neck, New York
- Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study — San Francisco, California
- MRI Evaluation of Integrity Implant for Rotator Cuff Tears — Tampa, Florida
- Maximal Repair Versus Bridging Reconstruction with BioBrace® — Halifax, Nova Scotia
Explore by condition: All Rotator Cuff Tears clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.