The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
研究概览
简要总结
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.
详细描述
Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 to 75 y/o.
- •Alert consciousness
- •Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
- •The pain score measured by VAS at least 4 points
排除标准
- •Has received hyaluronic acid, PRP or steroid injection within 6 months
- •Has received NSAIDs or steroid within one week
- •Tumor or metastasis surrounding the knee joint
- •Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- •Patient who cant tolerance the balance test.
- •Thrombocytopenia or coagulopathy
研究组 & 干预措施
Platelet rich plasma + Hyaluronic acid
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group.
干预措施: platelet rich plasma + Hyaluronic acid (Drug)
Platelet rich plasma + normal saline
Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group.
干预措施: platelet rich plasma + normal saline (Drug)
结局指标
主要结局
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
时间窗: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status.
次要结局
- Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.(Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.)
- Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.(Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.)
- Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.(Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.)
- Change from baseline in analysis of synovial fluid on 6th month and one year after injection.(Pre-treatment, 6th month and one year after injection.)
研究者
Yung-Tsan Wu
Attending Physician
Tri-Service General Hospital