Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 7
- 主要终点
- Composite Clinical Success (CCS)
研究概览
简要总结
A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.
详细描述
Prospective, multicenter clinical study of the Calypso Knee System. 81 subjects were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale 0-100).
The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).
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
研究组 & 干预措施
Calypso
Calypso Knee System
干预措施: Calypso Knee System (Implantable Shock Absorber) (Device)
结局指标
主要结局
Composite Clinical Success (CCS)
时间窗: From baseline to 24 months
A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 1. Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points 2. Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points 3. Freedom from the following device-related serious adverse events: * Deep infection requiring surgical intervention (Both arms) * Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms) * Non-union (HTO only) 4. Maintenance of implant integrity as evaluated by radiographic assessment 5. Endpoint Subsequent Surgical Intervention (SSI)
次要结局
- WOMAC Pain Percent Change to Month 24(From baseline to 24 months)
- WOMAC Function Percent Change to Month 24(From baseline to 24 months)
- WOMAC Function Percent Change to Month 3(From baseline to 3 months)
- Time to Full Weight Bearing (Days)(Through study completion (Number of days to full weight bearing))
- WOMAC Pain Percent Change to Month 3(From baseline to 3 months)