Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Changes from baseline Visual Analogue Scale (VAS) value
研究概览
简要总结
Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees
This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
详细描述
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
- •VAS greater than 5
- •Between 40and 80 years of age
排除标准
- •Level IV arthritis of the knee
- •Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
- •Frontal deformity greater than 10 degrees
- •Ipsilateral pathology of the knee or ankle
- •Range of motion or flexibility of the knee less than 90 degrees
- •Deficit of knee extension greater than 15 degrees
- •Anticoagulation treatment, antiplatelet treatment
- •Hepatopathy
- •Hematological neoplastic pathology
- •Active infection
- •Fibromyalgia
- •Chronic fatigue syndrome
研究组 & 干预措施
Platelet rich plasma
Three intraarticular injection, one each fifteen days
干预措施: Platelet rich plasma (Biological)
Hyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Changes from baseline Visual Analogue Scale (VAS) value
时间窗: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
次要结局
- Effects on quality of life(Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration)
- All reported adverse events(Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration)
- Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value(Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration)