BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (NCT05997381)
REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears
🩺 Plain-English Summary (8th-Grade Level)
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
Who can join: Review the eligibility criteria below.
Location: ConMed — New Haven, Connecticut
Age range: 40 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 (1 Sites)
- ConMed — New Haven, Connecticut
📞 Contact the Study Coordinator
Phone: (727) 457-4955
Email: BioBraceRCT@ConMed.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 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.