NCT04000204已完成不适用
The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- The change from baseline VAS pain score at 6 months post-injection.
研究概览
简要总结
The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 35 to 85 years;
- •radiographic Kellgren-Lawrence grade II to III;
- •symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
- •average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
- •radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee <30mm.
排除标准
- •previous orthopedic surgery in the lower extremity;
- •disabling osteoarthritis of hip or ankle;
- •previous IAHA within 6 months;
- •IA steroid or joint puncture within 3 months;
- •characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
- •Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
- •confirmed or suspected pregnancy or lactating;
- •known allergy history to any avian protein or HA product.
结局指标
主要结局
The change from baseline VAS pain score at 6 months post-injection.
时间窗: 6 months post-injection
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
次要结局
- Adverse events reported from the baseline and during the study period(1, 3, 6, 9 and 12 months post-injection)
- Knee joint inflammatory state change by ultrasonic inspection(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- Visual analog scale (VAS) score for pain change(Baseline, 1, 3, 9 and 12 months post-injection)
- Visual analog scale (VAS) score for satisfaction change(1, 3, 6, 9 and 12 months post-injection)
- Timed Up-and-Go test (TUG) change(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- Single-leg stance test (SLS) change(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- Visual analog scale (VAS) score for stiffness change(Baseline, 1, 3, 6, 9 and 12 months post-injection)
研究者
研究点 (2)
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