An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Knee Joint
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
详细描述
It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time*.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.
- •Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form
排除标准
- •Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.
- •Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.
结局指标
主要结局
Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
时间窗: Screening, post op 2years
comparison of the difference between a group with Chondron Implantation and a group with Microfracture.
次要结局
- Score change of KSS(Knee Society Score)(Screening, Post op 2 years)
- Score change of 100 Vas(visual Analog System)(Screening, post op 2years)
- Score change of IKDC (International Knee Documentation Committee)(screening, post op 2 years)
- Comparing MRI results(Screening, Post op 2years)