EUCTR2015-004738-90-ESActive, not recruitingNot Applicable
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 sitesStarted: January 13, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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