BioPoly® Partial Resurfacing Knee Implant IDE

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.

NCT Number	NCT06915363
Lead Sponsor	BioPoly LLC
Conditions	Knee Pain Chronic, Knee Osteoarthritis, Cartilage Damage, Cartilage Defects of the Knee, Cartilage or Osteochondral Defects in the Knee, Cartilage Lesion
Enrollment	152 participants
Start Date	2025-03-17
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-08