🏛️ Verified NIH Record • Updated 2025-02-14

Maximal Repair Versus Bridging Reconstruction with BioBrace® (NCT05959733)

Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Nova Scotia Health Authority

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.

Who can join: Review the eligibility criteria below.

Location: Nova Scotia Health Authority — Halifax, Nova Scotia

Age range: 18 Years

🧪 Interventions in This Study

  • Bridging Reconstruction using BioBrace (PROCEDURE)
  • Repair (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (1 Sites)

  • Nova Scotia Health Authority — Halifax, Nova Scotia

📞 Contact the Study Coordinator

Phone: (902) 473-7626

Email: research@drivanwong.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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗