RecruitingNot ApplicableNCT06915363

BioPoly® Partial Resurfacing Knee Implant IDE

Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur


Sponsor

BioPoly LLC

Enrollment

152 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BioPoly and a procedure called surgical standard of care (SSOC) for people with cartilage damage, cartilage defects of the knee, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioPoly

partial resurfacing knee replacement

PROCEDUREsurgical standard of care (SSOC)

either microfracture or debridement


Locations(4)

Dupont Hospital

Fort Wayne, Indiana, United States

OrthoIndy

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Orthopedics

Chesterfield, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT06915363


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