NCT02179346已完成不适用
Observational Study on the Feasibility, Safety and Efficacy in the Biological Reconstruction of the Hip Joint With Full Thickness Cartilage Defects With an in Situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
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
- 21
- 试验地点
- 3
- 主要终点
- Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
研究概览
简要总结
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
详细描述
Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.
Safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.
Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 60 years
- •Insulated full thickness cartilage damage of the hip joint after ICRS grade 3
- •Received subchondral bone lamella
- •received or reconstructed labrum in labrum cartilage defects
- •defect size ≥ 1.5 and ≤ 10 cm2
- •Intact surrounding cartilage structure around the defect, and the corresponding articular surface
- •existence of the written informed consent of the patients after Enlightenment
排除标准
- •More than 2 defects or 2 corresponding defects
- •defects in both lower extremities simultaneously
- •Radiographic signs of osteoarthritis of Kellgren & Lawrence > 1
- •Profound bony lesion > 0.5 cm in the defect area
- •Presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases
- •Skin injury to the limb to be operated on
- •cartilage defect of the corresponding articular surface
- •Existing medications, drugs or alcohol
- •Acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases
- •impairment of the upper extremity, which prevents discharge by Crutches
- •Known bleeding disorder, such as Hemophilia A / B or thrombophilia
- •pregnancy and lactation, which represent the time of treatment is a contraindication
- •Known allergy to the ingredients
- •inmates in prisons
结局指标
主要结局
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
时间窗: 24 months
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
次要结局
- iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life(12 and 24 months)
- EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life(12 and 24 months)
研究者
研究点 (3)
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