Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
52
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
- VAS greater than 5
- Between 40and 80 years of age
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Platelet rich plasma
Three intraarticular injection, one each fifteen days
|
Three intraarticular injections of platelet-rich plasma, one each fifteen days
其他名称：
|
|
有源比较器：Hyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)
|
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes from baseline Visual Analogue Scale (VAS) value
大体时间：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
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
大体时间：Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
KOOS is an instrument to assess the patient's opinion about their knee and associated problems.
It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
|
Effects on quality of life
大体时间：Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
EUROQOL (European Quality of Life) for the evaluation of function and quality of life
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
|
All reported adverse events
大体时间：Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elvira Montañez Heredia, MD, PhD、Hospital Universitario Virgen de la Victoria. Malaga
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年11月1日
研究注册日期
首次提交
2015年4月27日
首先提交符合 QC 标准的
2015年5月15日
首次发布 (估计)
2015年5月19日
研究记录更新
最后更新发布 (估计)
2015年5月19日
上次提交的符合 QC 标准的更新
2015年5月15日
最后验证
2015年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.