Randomized Clinical Trial of BioPoly Partial Resurfacing Knee Implant Versus Standard Surgery for Cartilage Damage in Adults Aged 30 to 65

What this Trial Is About

Researchers are evaluating the BioPoly4 Partial Resurfacing Knee Implant as a treatment option for adults aged 30 to 65 years who have cartilage defects in the distal femur causing knee pain and symptoms. The study compares the safety and effectiveness of the BioPoly device to standard surgical treatments, which include microfracture or debridement. The trial aims to assess whether the implant improves clinical outcomes, specifically focusing on a combination of no additional knee surgeries and meaningful improvement in knee function scores over 24 months. Participants are randomly assigned to receive either the BioPoly implant or one of the standard surgical procedures microfracture or debridement based on a treatment algorithm considering age, osteoarthritis severity, and lesion size. The BioPoly device replaces damaged cartilage in the femoral condyles or trochlear facets and is intended for focal lesions with healthy surrounding cartilage. The study includes a two-year follow-up period to monitor the results and safety of each treatment. During the study, participants will undergo assessments including the Knee injury and Osteoarthritis Outcome Score KOOS, radiographs to check implant stability, and evaluation for any adverse events or additional surgeries. Researchers will collect data at regular intervals up to 24 months to measure pain reduction, function, and implant survival. Participants are expected to comply with post-operative rehabilitation and follow-up visits throughout the study duration.

BioPoly® Partial Resurfacing Knee Implant IDE