BioPoly® Partial Resurfacing Knee Implant for Knee Pain and Cartilage Damage
This study is testing the BioPoly® Partial Resurfacing Knee Implant for people with knee pain and cartilage damage. It's for adults aged 30 to 65 whose knee pain hasn't improved with other treatments. Researchers want to see if this implant is safe and works better than standard surgeries like microfracture or debridement. Success in this study means you don't need another knee surgery and your Knee injury and Osteoarthritis Outcome Score (KOOS) improves by at least 10 points. The study is currently unclear on its recruitment status, but plans to enroll 152 participants.
- Study design
- This is a randomized controlled study comparing the BioPoly® implant to standard surgical care, with 152 planned participants.
- What's involved
- You would need to comply with all study requirements, including post-operative rehabilitation and follow-up protocols.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be followed for 24 months after the surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BioPoly® Partial Resurfacing Knee Implant IDE
At a glance
Conditions
NCT06915363
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Recruiting
OrthoIndy
Indianapolis, Indianastudy coordinator listed
Recruiting
Washington University Orthopedics
Chesterfield, Missouristudy coordinator listed
Recruiting
Dupont Hospital
Fort Wayne, Indianano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Herb Schwartz, Ph.D. · STUDY_DIRECTOR · BioPoly LLC
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness24 months
An improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. If this criteria is met, the subject will be considered as a success relative to the measure of the Clinical Composite Success for effectiveness.
- Composite Clinical Success (CCS) Safety as Measured by No Secondary Surgical Intenvention24 months
No secondary surgical intervention (SSI) by 24 months will be considered as a success for the subject relative to the Composite Clinical Success (CCS) for Safety.