NCT02002637终止不适用
Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients With Medial Osteoarthritis - A Safety Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cotera, Inc.
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Freedom from unanticipated serious adverse device effects
研究概览
简要总结
The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of pain as due to medial osteoarthritis
排除标准
- •Rheumatoid arthritis
- •Joint or ligament instability
- •Metal ion allergy
结局指标
主要结局
Freedom from unanticipated serious adverse device effects
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (2)
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