500
Participants
Start Date
April 8, 2025
Primary Completion Date
June 30, 2030
Study Completion Date
June 30, 2030
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.
Arthroscopic anterior cruciate ligament reconstruction
An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.
RECRUITING
ConMed, New Haven
Lead Sponsor
CONMED Corporation
INDUSTRY