Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.
详细描述
Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.
120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)
Primary outcome: - clinical outcome (pain using numeric rating scale)
- Magnetic Resonance imaging (cartilage defects etc.)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Triamcort (1 ml, 40 mg/ml)
30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200)
干预措施: Triamcort (Drug)
Platelet-rich-plasma (PRP 3 ml)
30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200)
干预措施: Platelet-rich-plasma (Drug)
Suplasyn1-shot (60 mg/ ml)
30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200)
干预措施: Suplasyn1 (Drug)
Placebo (Iopamiro 200)
30 patients receive intraarticular injection with contrast media only
干预措施: Placebo (Drug)
结局指标
主要结局
Pain assessment
时间窗: up to 24 months after injection
numeric rating scale (NRS) and WOMAC
Magnetic Resonance imaging
时间窗: up to 12 months after injection
T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions
次要结局
- WOMAC score (stiffness, difficulty)(up to 24 months after injection)
- Knee mobility and thigh circumference(3 month after injection)
- Tegner Activity Scale(up to 24 months after injection)