NCT07621172已完成不适用
Observational Study to Evaluate the Long-term Safety and Efficacy of CartiFill in Subjects With Cartilage Defect of the Knee Joints Who Have Undergone Microfracture Surgery or Microfracture Surgery Using Collagen
Cellontech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年2月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of CartiFill implanted at the site of knee joint cartilage defect in a 6-year, long-term, follow-up investigation.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone microfracture surgery or microfracture surgery using collagen 6 years (±1 year) ago as part of the previously conducted post-marketing clinical trial (Protocol No. 03CAR).
- •Males or females aged 19 to 70 years.
- •Patients or patients whose legal representatives have agreed to participate in the clinical trial and signed the written consent.
排除标准
- •Patients who have undergone microfracture surgery or microfracture surgery using collagen as part of previously conducted post-marketing clinical trial (Protocol No. 03CAR) but have since then received cartilage surgery, such as high tibial osteotomy (HTO), partial/full implant arthroplasty, etc., at the same site. (Does not include biopsy for diagnosis, a simple arthroscopic examination, or HTO plate removal procedure, etc.)
- •※ Does not include non-invasive treatment or medication such as exercise therapy, physical therapy, manual therapy, extracorporeal shock wave, joint cavity injection, etc.
- •Patients who are deemed by the clinical trial manager to be unfit to participate due to psychiatric conditions, etc.
研究者
研究点 (1)
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