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NCT06915363 · ClinicalTrials.gov registry record · NA
BioPoly® Partial Resurfacing Knee Implant IDE
A NA study of Knee Osteoarthritis and Knee Pain Chronic, sponsored by BioPoly.
- Recruiting
- Registry status
- NA
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT06915363 is a NA study of Knee Osteoarthritis and Knee Pain Chronic that is actively recruiting participants, run by BioPoly. The registered enrollment target is 152 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06915363, a NA study of Knee Osteoarthritis and Knee Pain Chronic, is actively recruiting participants, sponsored by BioPoly.
- RECRUITING
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE BioPoly
- PROCEDURE surgical standard of care (SSOC)
Study Locations (1)
Indiana
- Dupont Hospital - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2028-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06915363
The ClinicalTrials.gov registry entry for NCT06915363 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (50% lower). The listed sponsor is BioPoly, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which BioPoly is the first listed.
NCT06915363 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT06915363 about?
NCT06915363 is a clinical study titled "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 ...
What is the current status of trial NCT06915363?
This trial is currently recruiting. It is a NA study. The enrollment target is 152 participants. The study started on 2025-03-17. Estimated completion is 2028-12.
What conditions does trial NCT06915363 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Knee Pain Chronic, Cartilage Damage, Cartilage Defects of the Knee, Cartilage or Osteochondral Defects in the Knee.
What interventions are being tested in trial NCT06915363?
The interventions under investigation include: BioPoly (DEVICE), surgical standard of care (SSOC) (PROCEDURE).
Who is sponsoring clinical trial NCT06915363?
This trial is sponsored by BioPoly, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06915363 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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