Clinical Trial

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Study acronym: REinForce
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-08-10; most recent amendment 2026-04-20.
Status change: Enrolling by Invitation → Recruiting 2025-09-11
Status change: Recruiting → Enrolling by Invitation 2024-05-06
Status change: Not Yet Recruiting → Recruiting 2024-01-10
Trial Details
NCT Number NCT05997381
Lead Sponsor CONMED Corporation
Conditions Rotator Cuff Tears
Enrollment 268 participants
Start Date 2024-01-05
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-23