Knee Osteoarthritis Clinical Trial
Official title:
Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care
This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation
The main objective is to get a 50% proportion of responders defined by answers "absent" or
"light" in the KOOS questionnaire on questions about pain and difficulty walking on flat
ground.
Secondary objectives include the safety validation of the use of PRP (prepared standardized
manner by means of a given medical device) as second-line standard of care for osteoarthritis
by the introduction of a systematic monitoring; and the feasibility of the health care system
dedicated to the treatment of knee osteoarthritis by autologous PRP.
Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS)
and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be
performed within 15 days prior (inclusion visit) injection and 6 months to assess the
cartilage thickness and visualize a regenerative effect.
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