NCT01209390终止不适用
A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
TiGenix n.v.4 个研究点 分布在 4 个国家目标入组 8 人开始时间: 2010年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Safety data
研究概览
简要总结
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.
The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.
The secondary objectives are:
- Clinical outcome as assessed by patient reported EuroQoL-5D
- Structural repair as assessed by MRI
- The number of treatment failures and the time to treatment failure
- The ease of use of ChondroMimetic as reported by the surgeon
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed patient informed consent
- •Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
- •Agree to actively participate in a rehabilitation protocol
排除标准
- •Severe vascular or neurological disease
- •Uncontrolled diabetes
- •Severe degenerative joint disease
- •Presence of infection at the site or in the joint space (e.g. osteomyelitis)
- •Diagnosis rheumatoidism
- •Advanced osteoarthritis as judged by the surgeon
- •Drug and/or alcohol abuse
- •Hypercalcemia
- •Known allergy to any of the components of the device (e.g. bovine collagen)
- •Bleeding disorders of any etiology
- •Steroidal or immunosuppressive maintenance therapy
结局指标
主要结局
Safety data
时间窗: on ongoing basis up to 3 years
Safety data as measured by adverse device reactions
次要结局
- EuroQoL-5D(baseline, 6, 12, 24, 36 months)
- MRI(baseline, 12, 24, 36 months)
- Failure rate(3 years)
研究者
研究点 (4)
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