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BioPoly® Partial Resurfacing Knee Implant IDE
NCT06915363 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioPoly, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06915363 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06915363?
The interventions under investigation include: BioPoly (DEVICE), surgical standard of care (SSOC) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06915363?
This trial is sponsored by BioPoly, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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