Efficacy, safety and systemic effect of intra-articular and intraosseous infiltrations of Platelet Rich Plasma in patients with knee osteoarthritis: Randomized Clinical Trial

Arthroscopic Surgery Unit0 个研究点开始时间: 2016年1月13日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•Patients of both sexes aged between 40 and 85 years old.
•Diagnosed with osteoarthritis predominantly in the medial tibiofemoral compartment through X-ray knee clinical study.
•Joint pain than or equal to 2.5 points in VAS.
•Radiological severity grades 1, 2, 3, 4 according to the Ahlbäck scale.
•Values of Body Mass Index between 20 and 35.
•Serological tests negative against syphilis, HIV, HBV and HCV.
•Possibility for observation during the monitoring period
•Signed informed consent
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Gonarthrosis requiring infiltration in both knees
•Mechanical deformity requiring osteotomy.
•Previous arthroscopy in the last year.
•Intra-articular injection of hyaluronic acid in the last 6 months.
•Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
•Poorly controlled diabetes (glycosylated hemoglobin above 9%)
•Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9).
•It is undergoing immunosuppressive treatments.
•Treatment with steroids during the 6 months prior to inclusion in the study.
•Patients unable to stop treatment with NSAIDs during the study.
•Pregnancy and lactation.
•Polyarticular disease diagnosed.

发起方

Arthroscopic Surgery Unit