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
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 design
Treatments tested in this trial
- Anterior cruciate ligament reconstruction with BioBrace® augmentation
- Arthroscopic anterior cruciate ligament reconstruction
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov