NCT03484091已完成4 期
Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months
- •Gave informed consent
- •Can do questionnaires
排除标准
- •Severe deformity (varus or valgus from a mechanical axis more than 10 degrees
- •Allergy to hyaluronic acid
- •Pain in the hip or ankle
- •Post-traumatic or post surgery of lower extremity
- •Post-infection of the knee
- •Previous hyaluronic acid injection within 6 months
- •Pregnancy or lactation
- •Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion
研究组 & 干预措施
H group
Experimental
Single dose of Hyruan-One 3 mL intra-articular knee injection.
干预措施: Hyruan-One (Drug)
S group
Active Comparator
Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.
干预措施: Hylan G-F 20 (Drug)
N group
Placebo Comparator
Single dose of normal saline 6 mL intra-articular knee injection.
干预措施: Normal saline (Drug)
结局指标
主要结局
Pain level
时间窗: 6 months after injection
visual analog scale for pain (0-100) in between groups
Change from pre-injection pain level at 6 months
时间窗: 6 months
compare visual analog scale for pain (0-100) between pre-injection and post-injection
次要结局
- Time up and go test(post-injection 1, 3, 6 months)
- pain level in any time pints(post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks)
- Modified WOMAC(post-injection 2 weeks, 1, 2, 3,4, 5, 6 months)
- Lequesne index(post-injection 2 weeks, 1, 2, 3,4, 5, 6 months)
- SF-36(post-injection 2 weeks, 1, 2, 3,4, 5, 6 months)
- Complications(post-injection 1, 2 weeks)
研究者
Supakit Kanitnate
Department of orthopaedics
Thammasat University
研究点 (1)
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