NCT01056900已完成不适用
An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change of KSS(Knee Society Score)-A,B
研究概览
简要总结
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
详细描述
Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage.
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged between 15 and 65
- •Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
- •Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance
- •Patients whose surrounding cartilage is normal
- •Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial
排除标准
- •Patients hypersensitive to bovine protein
- •Patients hypersensitive to antibiotics like gentamicin
- •Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
- •Patients with arthritis associated with autoimmune diseases
- •Patients who are pregnant, nursing a baby or likely to get pregnant
- •Patients with other diseases including tumors except for cartilaginous defects of joints
- •Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
- •Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them)
- •Patients with infections who are taking antibiotics and antimicrobial agents
- •Patients who are treated with adrenal cortical hormones
- •Patients whom the investigators find to be unfit for this clinical trial, such as mental patients
结局指标
主要结局
Change of KSS(Knee Society Score)-A,B
时间窗: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.
次要结局
- Additional treatment related to autologous chondrocyte implantation(post -operation 4month, post-operation 12month, over post-operation 24month.)
- Satisfaction of patients(post -operation 4month, post-operation 12month, over post-operation 24month.)
研究者
研究点 (1)
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