Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Three intraarticular injections of platelet-rich plasma, one each fifteen days
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
Changes from baseline Visual Analogue Scale (VAS) value
The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Effects on quality of life
EUROQOL (European Quality of Life) for the evaluation of function and quality of life
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
All reported adverse events
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
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