Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to monitor and follow the evolution of the knee function
研究概览
简要总结
This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation
详细描述
The main objective is to get a 50% proportion of responders defined by answers "absent" or "light" in the KOOS questionnaire on questions about pain and difficulty walking on flat ground.
Secondary objectives include the safety validation of the use of PRP (prepared standardized manner by means of a given medical device) as second-line standard of care for osteoarthritis by the introduction of a systematic monitoring; and the feasibility of the health care system dedicated to the treatment of knee osteoarthritis by autologous PRP.
Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS) and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
study for knee osteoarthritis patients treated in the center
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 20 to 80 years
- •Gonarthrosis diagnostic objectified by the criteria of the American College of Rheumatology
- •Joint pain for more than 6 months
- •Answer "moderate" to the question about pain walking on flat ground
- •Answer "moderate" to the question about trouble walking on flat ground
- •Osteoarthritis stage 2 or 3 on the scale of Kellgren Lawrence (objectified radiography) within 6 months previous inclusion
- •Axial deformation of less than or equal to 5 ° lower limbs
- •Informed consent signed by the patient
- •HB> 10g / dl
- •Beta-HCG negative at baseline
- •Ability to perform the procedures in the follow-up (50 not walk on a flat surface and up / down stairs).
- •Being affiliated to a system of health insurance
排除标准
- •Axial deformation > 5 °
- •Ligamentous instability
- •Significant injuries or target knee or knee surgery contralateral side in 12 months previous the inclusion visit
- •Ligament reconstruction in the 12 months précédants the inclusion visit
- •Need a cane or assistance to move
- •Thrombocytopenia <150 G / L
- •Thrombocytosis> 450 G / L
- •Known thrombopathy
- •Anemia HB <10g / dl
- •Active infections to HIV 1 and 2, Agp24, HCV Ab, Ag and HbS AcHbc, Ac HTLV I and II, TPHA
- •Chronic treatment with corticosteroids per os or older than 2 weeks
- •Injection intra-articular corticosteroid of less than 2 months
- •Intra-articular injection of hyaluronic acid of less than 6 months
- •NSAIDs or antiplatelet agent of less than 15 days
- •Inability to stop NSAIDs (including aspirin) 15 days before the injection and the week following the injection
- •Fever or recent illness
- •Autoimmune diseases
- •Inflammatory arthritis
- •Immune deficiency
- •Infectious diseases
- •Pregnant women
- •Adults legally protected (under guardianship and trusteeship)
- •People simultaneously participating in other biomedical research
研究组 & 干预措施
knee osteoarthritis patients.
therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation.
干预措施: autologous PRP. (Biological)
结局指标
主要结局
to monitor and follow the evolution of the knee function
时间窗: prior,1 month, 3 months, 6 months
(KOOS score)
to monitor and follow the evolution of pain
时间窗: prior,1 month, 3 months, 6 months
VAS to monitor and follow the evolution of pain
Evaluation of MRI
时间窗: prior,1 month, 3 months, 6 months
Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
次要结局
未报告次要终点
研究者
Denis Arniaud
MD
Hospital St. Joseph, Marseille, France