EUCTR2013-003982-32-ES进行中（未招募）不适用
Pilot study to evaluate combination of intraosseous with intra-articular infiltrations of plasma rich in growth factors (PRGF®-Endoret®) in the treatment of knee osteoarthritis.
Arthroscopic Surgery Unit0 个研究点开始时间: 2013年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both sexes aged 40 to 72 years.
- •Monocomparitemental internal tibiofemoral osteoarthritis knee diagnosed by radiological clinical study.
- •Joint Pain or above 2.5 VAS points.
- •Radiographic severity grades 3 and 4 according to the scale Ahlbäck.
- •Values ??of Body Mass Index between 20 and 30.
- •Possibility for observation during the follow up period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Bilateral knee osteoarthritis in both knees that requires infiltration
- •Polyarticular disease diagnosed.
- •Severe mechanical deformity (4th varus and16th valgus bidiafisarios )
- •Arthroscopy in the last year prior.
- •Intraarticular infiltration of hyaluronic acid in the past 6 months.
- •Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
- •Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
- •Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9).
- •Be undergoing immunosuppressive therapy and / or warfarin.
- •Treatment with corticosteroids during the 6 months prior to inclusion in the study.
研究者
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