Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.
详细描述
This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107
Change from 0MCM0107 baseline in Modified Cincinnati Rating System
时间窗: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
KOOS (Knee injury and Osteoarthritis Outcome Score
时间窗: Through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis
时间窗: Through study completion, an average of approximately 8 years follow-up
Morphological segmentation utilizing a programmed anatomical atlas for all bone and cartilage structures will be used to assess defect filling (using previous MRI scans from study 0MCM0107 as reference), and T2 mapping for cartilage repair tissue quality.
Osteochondral defect repair assessment
时间窗: Through study completion, an average of approximately 8 years follow-up
Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system.
次要结局
未报告次要终点