Continued Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met
研究概览
简要总结
Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.
详细描述
This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants age - 25 to 65 years
- •Body Mass Index (BMI) of < 35, Weight < 300 lbs
- •Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
排除标准
- •Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
- •Knee ligament or meniscal instability
- •Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
结局指标
主要结局
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met
时间窗: Change at 24 months relative to baseline
1. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain 2. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function 3. Freedom from applicable device-related SAEs requiring surgical intervention 4. Maintenance of Implant Integrity by Radiographic Review
次要结局
未报告次要终点