NCT05997381

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: CONMED Corporation · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.	An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.
PROCEDURE	Arthroscopic rotator cuff repair	An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-08-18
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study