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

Rotator Cuff Tears Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05997381
Study type Interventional
Source CONMED Corporation
Contact
Status Enrolling by invitation
Phase N/A
Start date January 5, 2024
Completion date December 2025
View Details
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