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RecruitingNCT06948591

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures

Sponsor

CONMED Corporation

Enrollment

500 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

ACL Tears

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

Min Age: 14 YearsMax Age: 70 Years

Inclusion Criteria11

  • Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
  • Between 14 and 70 years old at the time of surgery.
  • Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
  • Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
  • If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
  • International Knee Documentation Committee (IKDC)
  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
  • Patient-Reported Outcomes Measurement Information System (PROMIS-10)
  • Tegner Activity Scale (TAS)
  • Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
  • Positive diagnostic imaging by MRI at baseline indicating an ACL tear

Exclusion Criteria4

  • Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
  • Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
  • Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
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Interventions

DEVICEAnterior 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.

PROCEDUREArthroscopic anterior cruciate ligament reconstruction

An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Locations(1)

ConMed

New Haven, Connecticut, United States

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NCT06948591