BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Improvement in Function — 3 years post-op
Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery. - Adverse Events — Baseline, 6-months, 1-, 2-, and 3-years post-op
Evaluation of device-related adverse events
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| ConMed | New Haven | Connecticut | Recruiting |
More CONMED Corporation trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06948591 on ClinicalTrials.gov ↗ ← All trials in the USA