A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The value of the visual analogue scale pain (VAS)
研究概览
简要总结
The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain.
Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.
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
- •Degenerative osteoarthritis of the knee confirmed radiologically
- •Degenerative osteoarthritis of the knee replacement candidate
- •Walking ability in patients with or without external support
- •Baseline in pain VAS greater than 60
排除标准
- •Neoplastic disease
- •Immunosuppressive States
- •Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.
- •Patients who have undergone arthroscopic surgery on the last 3 months
- •Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)
- •Fibromyalgia or chronic fatigue syndrome
- •Liver disease
- •Deficit coagulation (blood dyscrasia)
- •Thrombocytopenia
- •Anticoagulant treatment
研究组 & 干预措施
platelet-rich plasma intra-articular knee injections
a single intra-articular injection of PRP in knee osteoarthritis
干预措施: platelet-rich plasma (Biological)
Corticosteroid intra-articular knee injections
a betamethasone and bupivacaine intra-articular injection
干预措施: Corticosteroid (Drug)
结局指标
主要结局
The value of the visual analogue scale pain (VAS)
时间窗: one month after the treatment
The difference between the baseline and the value of the scale one month after treatment
次要结局
- All reported adverse events(4 weeks, 3 and 6 months after treatment)
- the functional level of the knee KOOS(4 weeks, 3 and 6 months after treatment)
- Scale of the SF36 quality of life(4 weeks, 3 and 6 months after treatment)
- the value of pain visual analog scale according to(4 weeks, 3 and 6 months after treatment)