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

• Conditions: Knee osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-004738-90-ES
• Lead Sponsor: Arthroscopic Surgery Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
BMI> 35
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified