Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur
The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.
• Patient is between 30 and 65 years of age25.
• KOOS quality of life score ≤ 60.
• In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol.
• Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) after at least 2 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement/lavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.
• Patient has cartilage lesion located in the femoral condyle or trochlear facet.
• Patient has lesion(s) classified as ICRS grade 2, 3 or 4.
• Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an overall depth less than 4mm from the articulating surface.
• Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl.