NCT02608957终止不适用
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US 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
- 1
- 试验地点
- 4
- 主要终点
- Primary Safety Endpoint: Surgical re-intervention rate at 6 months
研究概览
简要总结
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of pain due to medial osteoarthritis
- •Qualifying baseline pain scores
- •Kellgren-Lawrence Grades 2-3
排除标准
- •Osteoporosis
- •Rheumatoid arthritis
- •Joint instability
- •Metal ion allergy
- •Permanent implant in or around the knee joint
- •Prior anterior cruciate ligament reconstruction
结局指标
主要结局
Primary Safety Endpoint: Surgical re-intervention rate at 6 months
时间窗: 6 Months
Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
时间窗: 6 Months
Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.
次要结局
- Procedure-related complications rate(24 Months)
- Change in KOOS function score(6, 12 and 24 months)
- Change in IKDC score(6, 12 and 24 months)
- Device-related complications rate(24 months)
- Surgical re-intervention rate(12 and 24 months)
- Change in KOOS pain score(12 and 24 months)
- Change in medial knee pain NRS (while walking)(6, 12 and 24 months)
- Proportion of subjects reaching MCID in KOOS pain score(6, 12 and 24 months)
- KOOS responder rate based on OARSI-OMERACT criteria(6, 12 and 24 months)
研究者
研究点 (4)
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