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ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee

NCT01110070 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-07-07

No results posted yet for this study

Summary

The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.

Conditions

  • Cartilage Defect

Interventions

DEVICE

ChonDux

Comparison of ChonDux plus microfracture to microfracture only

DEVICE

ChonDux

single use device

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2012-12-31

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

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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 NCT01110070 on ClinicalTrials.gov