Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in pain, function, quality of life and activity level in knee osteoarthritis
研究概览
简要总结
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.
详细描述
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the knee, using parameters of pain, function, quality of life and safety.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40-75 years old
- •diagnosed Oa of the knee more then 1 year
- •no knee deformation
排除标准
- •mental of physical disabilities
- •pregnancy
- •deformities of the knee
研究组 & 干预措施
Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml of platelet-derived preparation rich in growth factors
干预措施: Platelet Rich Plasma (Preparation Rich in Growth Factors) (Biological)
Hyaluronic acid
Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease
干预措施: Platelet Rich Plasma (Preparation Rich in Growth Factors) (Biological)
Hyaluronic acid
Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Improvement in pain, function, quality of life and activity level in knee osteoarthritis
时间窗: 1 -2 years
Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.
次要结局
未报告次要终点