A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros-TA Joint Therapy for Management of Pain Associated With Osteoarthritis in the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- WOMAC VAS Pain over 26 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
详细描述
The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.
The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
排除标准
- •Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- •Generalized symptomatic OA in lower extremity joints other than the knees.
- •Active infection in either knee joint or adjacent tissues.
- •Any contraindications for intra-articular injection or aspiration.
- •Knee surgery or trauma within 3 months prior to enrollment.
- •Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment.
- •Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
- •Body Mass Index (BMI) greater than 35.
结局指标
主要结局
WOMAC VAS Pain over 26 weeks
时间窗: 26 weeks post treatment
次要结局
- WOMAC VAS Stiffness and Function over 26 weeks(26 weeks post treatment)