NCT03160781已完成2 期
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.
Unidad de Cirugía Artroscópica0 个研究点目标入组 19 人开始时间: 2014年1月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Pain according to KOOS scale at 6 months after treatment
研究概览
简要总结
The aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.This study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.
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
入排标准
- 年龄范围
- 40 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 40 to 77 years.
- •Predominant internal tibiofemoral knee osteoarthritis.
- •Joint pain above 2.5 VAS points.
- •Radiographic severity degrees 3 and 4 according to Ahlbäck scale.
- •Values of body mass index between 20 and
- •Possibility for observation during the follow-up period.
排除标准
- •Bilateral knee osteoarthritis which requires infiltration in both knees.
- •Values of body mass index >
- •Polyarticular disease diagnosed.
- •Severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘).
- •Arthroscopy in the last year prior to treatment.
- •Intra-articular 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, and anemia with Hb < 9).
- •Undergoing immunosuppressive therapy and/or warfarin.
- •Treatment with corticosteroids during the 6 months prior to inclusion in the study.
结局指标
主要结局
Pain according to KOOS scale at 6 months after treatment
时间窗: 6 months
Pain according to KOOS scale
次要结局
- Symptoms according to KOOS scale at 6 months after treatment(6 months)
- Function according to KOOS scale at 6 months after treatment(6 months)
- Sport Activity according to KOOS scale at 6 months after treatment(6 months)
- QoL according to KOOS scale at 6 months after treatment(6 months)
研究者
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