Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Incidence of related adverse events
研究概览
简要总结
The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.
详细描述
This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.
All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.
Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a symptomatic articular cartilage defect in the knee
排除标准
- •Surgery on the study knee joint within 6 months
- •Patients with significant malalignment (more than 5°)
- •Patients with ligamentous instability of the knee
- •Majority of the meniscus absent
- •Severe osteoarthritis
- •Intake of medications or treatments having an effect on bone or cartilage formation
结局指标
主要结局
Incidence of related adverse events
时间窗: Over 24 months
Lesion filling
时间窗: 3 months
次要结局
- Incidence of non-related adverse events(24 months)
- KOOS, IKDC and pain VAS scores(At all timepoints over 24 months)
- Histopathology assessments(6 or 12 months)
- MRI evaluation of structural repair(Discharge, 3, 6, 12 and 24 months)
- dGEMRIC assessment of structural repair(6, 12 and 24 months)