BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

RecruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

April 8, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2030

Conditions
ACL Tears
Interventions
DEVICE

Anterior cruciate ligament reconstruction with BioBrace® augmentation

An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® 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 ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graft construct. BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care ACL reconstruction techniques.

PROCEDURE

Arthroscopic anterior cruciate ligament reconstruction

An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Trial Locations (1)

06513

RECRUITING

ConMed, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CONMED Corporation

INDUSTRY

NCT06948591 - BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures | Biotech Hunter | Biotech Hunter