Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients With Closed Epiphyses
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tetec AG
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
研究概览
简要总结
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.
详细描述
The present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® 3D in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates.
In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.
The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis).
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 - 17 years old
- •Medicinal indication for NOVOCART 3D treatment
- •Exclusion criteria:
排除标准
- 未提供
结局指标
主要结局
Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
时间窗: 24 months Follow Up (FU)
Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome)
次要结局
- Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment(3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)
- Change of 5 subscores KOOS(24 months FU)
- IKDC subjective(24 month FU)
- pain VAS(24 month FU)
- MOCART(24 month FU)
- KOOS responder rate(24 month FU)
- IKDC subjective responder rate(24 months FU)
- Proportion of patients with Treatment failures(3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)
- Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment(3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)
- Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment(3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)