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BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Sponsor: CONMED Corporation
Summary
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
Official title: Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
Key Details
Gender
All
Age Range
14 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-04-08
Completion Date
2030-06
Last Updated
2025-11-26
Healthy Volunteers
Not specified
Conditions
Interventions
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.
Locations (1)
ConMed
New Haven, Connecticut, United States