NCT01110070

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

Pivotal Study in Europe for CE Mark

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.

Conditions

• Cartilage Defect

Interventions

Type	Name	Description
DEVICE	ChonDux	Comparison of ChonDux plus microfracture to microfracture only
DEVICE	ChonDux	single use device

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2010-04-26
• Last updated: 2017-07-07

Locations

7 sites across 3 countries: Austria, Germany, Netherlands