Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
CONMED Corporation
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.
Description
This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.
Eligibility
- Age range
- 14–70 years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. 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®. 2. Between 14 and 70 years old at the time of surgery. 3. Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study. 4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection. 5. If the subject has already undergone ACLR within t…
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.
Location
- ConMedNew Haven, Connecticut