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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.
ConMed
New Haven, Connecticut, United States
RECRUITINGImprovement 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
Adverse Events
Evaluation of device-related adverse events
Time frame: Baseline, 6-months, 1-, 2-, and 3-years post-op
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
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
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
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
Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Patient-reported functional and activity status as assessed by the following: Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months, 1-, 2-, and 3-years post-op
Secondary Surgical Intervention(s)
The percentage of subjects who required additional surgical procedures following discharge from the BioBrace ACLR index procedure will be reported.
Time frame: 6 months, 1-, 2-, and 3-years post-op
Re-tear Rate
Re-tear rate of the surgically reconstructed ACL tissue graft augmented with BioBrace. The percentage of subjects who experienced a re-tear of the augmented ACL tissue graft will be reported.
Time frame: 6 months, 1-, 2-, and 3-years post-op