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BioPoly® Partial Resurfacing Knee Implant IDE

NCT06915363 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-04-17

No results posted yet for this 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

  • Knee Pain Chronic
  • Knee Osteoarthritis
  • Cartilage Damage
  • Cartilage Defects of the Knee
  • Cartilage or Osteochondral Defects in the Knee
  • Cartilage Lesion

Interventions

DEVICE

BioPoly

partial resurfacing knee replacement

PROCEDURE

surgical standard of care (SSOC)

either microfracture or debridement

Sponsors & Collaborators

  • BioPoly LLC

    lead INDUSTRY

Principal Investigators

  • Herb Schwartz, Ph.D. · BioPoly LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915363 on ClinicalTrials.gov