FiberLocker® System Augmentation of Rotator Cuff Repairs (NCT06918041)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument). The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.
Who can join: Review the eligibility criteria below.
Location: Rush University Medical Center — Chicago, Illinois
Age range: 30 Years to 70 Years
🧪 Interventions in This Study
📋 "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 (4 Sites)
- Rush University Medical Center — Chicago, Illinois
- MedStar Health Research Institute — Columbia, Maryland
- Wake Forest University — Winston-Salem, North Carolina
- Southern Oregon Orthopedics Research Foundation — Medford, Oregon
📞 Contact the Study Coordinator
Phone: (312) 432-2337
Email: nicholson.research@rushortho.com
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 Tear
- Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears — Phoenix, Arizona
- Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears — New York, New York
- Rotator Cuff Failure With Continuity — Cleveland, Ohio
- Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation — New York, New York
- Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears — Toronto, Ontario
Explore by condition: All Rotator Cuff Tear 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.