Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART Inject for the Treatment of Cartilage Defects in the Knee in Pediatric Patients With Closed Epiphyses
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Tetec AG
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Responder rate of overall KOOS
研究概览
简要总结
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates.
详细描述
In this non-interventional study NOVOCART® Inject, which is marketed in Germany under a license according to Section 4b of the AMG, will be used in routine clinical practice according to the current authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® Inject may only be used by physicians who are trained on the product. The treatment with NOVOCART® Inject requires two surgeries. During the first surgery cartilage tissue will be harvested arthroscopically and sent to TETEC AG for NOVOCART® Inject manufacturing, then NOVOCART® Inject will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® Inject implantation and data will be collected preoperatively and at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® Inject 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® Inject implantation (primary analysis).
Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (< 18 years of age at implantation)
- •Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality
- •Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee
- •Medicinal indication for NOVOCART® Inject treatment
排除标准
- •see NOVOCART Inject SmPC
结局指标
主要结局
Responder rate of overall KOOS
时间窗: 24-months Follow-up
The overall Knee injury and Osteoarthritis Outcome Score (KOOS5) responder rate defined as the proportion of patients with ≥ 10 points improvement in the KOOS5 from baseline.
次要结局
- Change of overall KOOS from baseline(24-months Follow-up)
- Change of the 5 sub-scores of the KOOS from baseline(24-months Follow-up)
- Change of the IKDC subjective score from baseline(24-months Follow-up)
- Number of postop physical therapy(24-months Follow up, 60-months Follow-up)
- Change in the IKDC surgeon's part from baseline(24-months Follow-up)
- MOCART (MRI imaging)(24-months Follow-up)
- IKDC subjective score responder rate(24-months Follow-up)
- Work/school status checklist(24-months Follow up, 60-months Follow-up)
- Proportion of patients with treatment failure(24-months Follow up, 60-months Follow-up)
- Days of work/school missed(24-months Follow up, 60-months Follow-up)
- Rate of unplanned re-operations(24-months Follow up, 60-months Follow-up)
- Surgical time(24-months Follow up, 60-months Follow-up)
- Number of postop doctor visits(24-months Follow up, 60-months Follow-up)
- Days of hospitalisation(24-months Follow up, 60-months Follow-up)
- Treatment-related adverse reactions (ARs)(24-months Follow up, 60-months Follow-up)
- Patient satisfaction(24-months Follow up, 60-months Follow-up)
- Length of incision(24-months Follow up, 60-months Follow-up)