BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (REinForce)
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
Sponsor: CONMED Corporation
This observational or N/A phase trial investigates Rotator Cuff Tears and is currently actively recruiting participants. CONMED Corporation leads this study, which shows 11 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical study investigating the treatment of full thickness tears of the rotator cuff. Tears must involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and \< 5 cm. Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome measures and MRI to assess repair integrity and re-tear rate.
This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical study investigating the treatment of full thickness tears of the rotator cuff. Tears must involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and \< 5 cm. Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome measures and MRI to assess repair integrity and re-tear rate.
Status Flow
Change History
11 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
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Apr 16, 2026 — Apr 28, 2026 [daily]
Recruiting
Phase: NA → None
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Oct 2025 — Apr 2026 [monthly]
Recruiting NA
Status: Enrolling By Invitation → Recruiting
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Sep 2025 — Oct 2025 [monthly]
Enrolling By Invitation NA
-
Aug 2025 — Sep 2025 [monthly]
Enrolling By Invitation NA
▶ Show 6 earlier versions
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Jan 2025 — Aug 2025 [monthly]
Enrolling By Invitation NA
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Sep 2024 — Jan 2025 [monthly]
Enrolling By Invitation NA
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Jul 2024 — Sep 2024 [monthly]
Enrolling By Invitation NA
-
Jun 2024 — Jul 2024 [monthly]
Enrolling By Invitation NA
Status: Recruiting → Enrolling By Invitation
-
Feb 2024 — Jun 2024 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Sep 2023 — Feb 2024 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- CONMED Corporation
For direct contact, visit the study record on ClinicalTrials.gov .