Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 38
- 主要终点
- The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.
研究概览
简要总结
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
详细描述
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
- •Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
- •Are normally active, without aid of mobility devices(such as crutch, walker or cane)
排除标准
- •Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
- •Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
- •Have received steroid injections in any joint in last 3 months
- •Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
结局指标
主要结局
The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.
时间窗: At 4, 12 and 26 weeks post 3rd injection
次要结局
- Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis.(At 4, 12 and 26 weeks post 3rd injection)