ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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