CTRI/2021/05/033302已完成不适用
An open label comparative study to evaluate safety and effectiveness of intraarticularinjection of Autologous Growth Factor Concentrate (AGFC) versusHyaluronic acid (HA) in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change from baseline of Western Ontario and McMaster
研究概览
简要总结
To evaluate Safety and Effectiveness of intra-articular injection of Autologous
Growth Factor Concentrate (AGFC) versus Hyaluronic acid (HA) in Knee
Osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed osteoarthritis of the knee joint on radiological assessment (Grade I, II & III on Kellgren-Lawrence Grading Scale) and
- •Visual Analogue Scale (VAS) pain score of 4 or more (on numeric rating scale) since past 2 weeks in spite of taking NSAIDs.
排除标准
- •Grade IV on Kellgren-Lawrence Grading Scale
- •Past surgery or fracture on knee joint
- •Knee instability.
结局指标
主要结局
Change from baseline of Western Ontario and McMaster
时间窗: Baseline and Month 11]
Universities Osteoarthritis Index score (WOMAC)
时间窗: Baseline and Month 11]
次要结局
- Change from baseline of VAS pain numeric rating scale(Baseline, Month 1, Month 2, Month 5, Month 8, and Month)
- Change from baseline of WOMAC score(Baseline,)
研究者
研究点 (6)
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