NCT02348697已完成不适用
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tetec AG
- 入组人数
- 81
- 试验地点
- 9
- 主要终点
- Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
研究概览
简要总结
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.
详细描述
A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adult patients
- •Children and adolescents with closed epiphysial plate
- •Defect size ≥2.5 and ≤10 cm2 post-debridement
- •Localized full thickness articular cartilage defect of the knee (Grade 3 & 4 International Cartilage Repair Society (ICRS) classification)
排除标准
- •Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2
- •More than 2 defects or 2 corresponding lesions
- •Ankylosis
- •Arthrofibrosis
- •Diffuse chondromalacia
- •Total/subtotal resected meniscus
- •Insufficient Ligament guidance
- •Patella malignement
- •Inflammatory joint disease
- •General cartilage degeneration or increased joint deterioration
- •Cancer, present or within the last 5 years
- •Primary treatment in children and adolescents with open epiphysial plate
- •Chronical infection diseases
- •Untreated coagulation disorder
- •Pregnancy and lactating
- •Known history of allergies against ingredients of NOVOCART® 3D
结局指标
主要结局
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
时间窗: 36 month
Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
次要结局
- Efficacy - International Knee Documentation Committee (IKDC) 2000(36 month)
研究者
研究点 (9)
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