A Prospective, Active Controlled, Randomised, Parallel Group, Double Blind, Multicentre Study to Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
研究概览
简要总结
To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥40 years old.
- •Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
- •Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.
排除标准
- •Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
- •Subject has a documented history of hypersensitivity to HA.
- •Subject has a documented infection or severe inflammation of the target knee joint.
- •Subject has a skin disease in the area of the injection site.
- •Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
- •Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
研究组 & 干预措施
Durolane®
干预措施: Durolane® (Device)
Hyruan ONE®
干预措施: Hyruan ONE® (Device)
结局指标
主要结局
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
时间窗: from Baseline to 13 weeks post injection.
The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question). Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows: Pain = 0-20 Stiffness = 0-8 Physical function = 0-68.
次要结局
未报告次要终点