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

Not Applicable

Terminated

• Conditions: Cartilage Defect
• Interventions: Device: ChonDux

• Registration Number: NCT01110070
• Lead Sponsor: Zimmer Biomet

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• A standing radiograph of the knee showing a Kellgren score of 0-2
• Body mass index ≤33
• An Outerbridge score of III or IV without need for bone graft
• A meniscus with no more than partial resection in the affected knee

Exclusion Criteria

• Passive motion deficit of the knee (>5º of extension, >15º of flexion)
• Moderate or severe osteoarthritis
• Diabetes mellitus (IDDM Type 1)
• Patellofemoral instability
• Malalignment with > 5° valgus or varus compared to contralateral knee
• Active osteomyelitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChonDux plus microfracture	ChonDux	-
Microfracture	ChonDux	-

Primary Outcome Measures

Name	Time	Method
Defect fill at 6 months determined by magnetic resonance imaging (MRI)	6 months

Secondary Outcome Measures

Name	Time	Method
Knee function as assessed by the IKDC questionnaire	6 months
Pain score (VAS)	6 months
SF-36 Health Survey	6 months

Trial Locations

Locations (7)

Ortho.Abteilung, AKH Linz; 🇦🇹 Linz, Austria

Krakenhaus Altentreptow; 🇩🇪 Altentreptow, Germany

Medalp; 🇦🇹 Imst, Austria

Orthopedic and Pain Center Freiberg; 🇩🇪 Freiberg, Germany

Meander Medical Center; 🇳🇱 Baarn, Netherlands

Tergooiziekenhuizen; 🇳🇱 Hilversum, Netherlands

University Mannheim; 🇩🇪 Mannheim, Germany