Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06948591

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Sponsor: CONMED Corporation

View on ClinicalTrials.gov

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

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.

Locations (1)

ConMed

New Haven, Connecticut, United States