BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
CONMED Corporation
Study ID
NCT06948591
Status
Recruiting
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Conditions

  • ACL Tears

Eligibility Criteria

Sex
ALL
Age
14 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Anterior cruciate ligament reconstruction with BioBrace® augmentation — DEVICE
    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 — PROCEDURE
    An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: BioBrace Augment Group
    An anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft.

Primary Outcome Measure

Improvement in Function [ Time Frame: 3 years post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ConMedNew HavenConnecticut06513

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By research site
ConMed· New Haven, CT

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