Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tetec AG
- 入组人数
- 245
- 试验地点
- 7
- 主要终点
- Number of adverse drug reaction/serious adverse drug reaction
研究概览
简要总结
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
详细描述
Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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 patients
- •juvenile patients with closed epiphysial plate
- •insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
- •defect size ≥ 2.5 and ≤ 10 cm2
- •intact or reconstructed bony subchondral plate
- •in the case of deep bony substance defects, additional bony reconstruction is needed
排除标准
- •radiographic signs of osteoarthritis of Kellgren and Lawrence > 2
- •joint stiffness
- •arthrofibrosis
- •malalignment in the knee (valgus- or varus deformity) > 3° (correction contemporary to the ACT)
- •insufficient reconstructed ligaments (correction contemporary to the ACT)
- •defective position patella (correction contemporary to the ACT)
- •sled prosthesis implants or carbon pin
- •inflammatory joint diseases (f.e. rheumatoid arthritis)
- •corresponding cartilage defects ("kissing lesions")
- •more than two independent cartilage defects in one knee
- •primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
- •diffuse chondromalacia
- •congenital or gained deformity of patella
结局指标
主要结局
Number of adverse drug reaction/serious adverse drug reaction
时间窗: Up to 24 months
Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety
次要结局
- Outcome of IKDC 2000(Up to 24 months)
- Outcome of KOOS(Up to 24 months)