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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pivotal Study in Europe for CE Mark

Conditions
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Cartilage Defect

Intervention / Treatment
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* Device: ChonDux
* Device: ChonDux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChonDux plus microfracture<br> | Device: ChonDux<br>* Comparison of ChonDux plus microfracture to microfracture only<br>|
| Active Comparator: Microfracture<br> | Device: ChonDux<br>* Comparison of ChonDux plus microfracture to microfracture only<br>Device: ChonDux<br>* single use device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defect fill at 6 months determined by magnetic resonance imaging (MRI) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS) |  | 6 months | 
| Knee function as assessed by the IKDC questionnaire |  | 6 months | 
| SF-36 Health Survey |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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articular, cartilage, microfracture, knee pain, cartilage repair, Subjects with an articular cartilage defect in the knee.