Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
详细描述
Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.
The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes and aged between 40 and 72 years.
- •Diagnosed with osteoarthritis of the knee by radiological image.
- •Pain in the joint equal to or greater than 2.5 points in EAV.
- •Radiological severity:Value in the Ahlback score 3 or less.
- •Body mass index between 20 and
- •Possibility for observation during follow-up period.
排除标准
- •Bilateral Gonarthrosis requiring infiltration in both knees.
- •Body mass index greater than
- •Diagnosed polyarticular disease.
- •Severe mechanical deformation.
- •Previous arthroscopy in the past year.
- •Intraarticular infiltration of hyaluronic acid in the last 6 months.
- •Rheumatic autoimmune systemic disease.
- •Poorly controlled diabetes mellitus.
- •Blood alterations.
- •Immunosuppressive treatments and/or coumarinics.
- •Treatment with steroids for 3 months prior to its inclusion in the study.
- •Treatment with nonsteroidal anti-inflammatory drugs for 15 days prior to its inclusion in the study.
结局指标
主要结局
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
时间窗: 6 months
次要结局
- Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)(6 months)
- Changes in Quality of life (SF-12 questionnaire).(6 months)
- Changes in Degree of joint mobility.(determined by goniometer).(6 months)
- Complications and/or adverse effects.(6 months)