Health TrialsbyHealthPanel

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

ConditionACL Tears
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-70
SponsorCONMED Corporation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Community surrounding participating hospitals / clinics.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: BioBrace Augment Group2 interventions

Trial outcomes

Primary outcomes

1

Improvement in Function

Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.

Time frame
3 years post-op
2

Adverse Events

Evaluation of device-related adverse events

Time frame
Baseline, 6-months, 1-, 2-, and 3-years post-op

Secondary outcomes

1

International Knee Documentation Committee (IKDC)

Patient-reported functional and activity status as assessed by International Knee Documentation Committee (IKDC)

Time frame
Baseline, 6 months, 1-, 2-years post-op
2

Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)

Patient-reported functional and activity status as assessed by the following: Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)

Time frame
Baseline, 6 months, 1-, 2-, and 3-years post-op
3

Patient-Reported Outcomes Measurement Information System (PROMIS-10)

Patient-reported functional and activity status as assessed by the following: Patient-Reported Outcomes Measurement Information System (PROMIS-10)

Time frame
Baseline, 6 months, 1-, 2-, and 3-years post-op
4

Tegner Activity Scale (TAS)

Patient-reported functional and activity status as assessed by: Tegner Activity Scale (TAS).

Time frame
Baseline, 6 months, 1-, 2-, and 3-years post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CONMED Corporation

Lead sponsor

Source ClinicalTrials.gov
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