Condition: Knee Pain Chronic · Knee Osteoarthritis · Cartilage Damage · Sponsor: BioPoly LLC
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.
This description comes directly from the study's public registry record.
Sheila Schwartz, R.Ph. · 2609996135 · sheila@biopolyortho.com
Always discuss trial participation with your own doctor first.
| Dupont Hospital | Fort Wayne, Indiana, United States | Recruiting |
| OrthoIndy | Indianapolis, Indiana, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Washington University Orthopedics | Chesterfield, Missouri, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06915363