Platelet-rich Plasma in Symptomatic Knee Osteoarthritis (PIKOA)
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial
Eligibility Criteria
Inclusion Criteria:
- Age between 40 and 79
- Symptomatic knee OA according to ACR criteria evolving for more than 3 months
- Predominantly femoro-tibial pain
- KL 2 or 3 on femorotibial compartment on X-rays of less than 6 months
- ENS ≥ 4/10 (with or without usual analgesic treatments)
- Failures or contraindications to conventional treatments (analgesics, NSAIDs)
- Patient able to understand the requirements of the trial and having signed a free and informed consent before entering the study
- Patient able to read and understand written instructions
- Patient able to complete the self-questionnaires
- Use of effective contraception in premenopausal women
Exclusion Criteria:
- Other pathologies of the lower limbs interfering with the evaluation of knee osteoarthritis (symptomatic hip OA, Lumbar pain…)
- Symptomatic contralateral knee OA with NRS ≥ 4/10
- Predominant patellofemoral symptoms
- Radiographic knee OA stage 1 or 4 of KL
- Predominant radiographic patellofemoral OA
- History of target knee surgery with material
- History of inflammatory or microcrystalline rheumatism
- History of fibromyalgia
- Morbid obesity (BMI> 40kgs / m2)
- Inflammatory flare (KOFUS score ≥ 7)
- Use of opioids in the month prior to inclusion
- Patient refusing to stop NSAIDs during the study and conventional analgesics 48 hours
- History of infection of the target knee
- Presence of chondrocalcinosis on the frontal x-ray
- Previous PRP injection
- Injection of HA or CS into the target knee during the last 3 months
- History of hemostasis disorders or taking a curative dose of anticoagulant
- Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)]
- Haematological disease in progress or in remission for less than 5 years (malignant hemopathies, myelodysplasia, autoimmune thrombocytopenia)
- Thrombocytopenia (<150,000 platelets)
- Patient undergoing treatment with chemotherapy or immunosuppressive drugs
- Infection at the time of inclusion (bacterial infection and / or presence of fever and / or taking antibiotics)
- Participation in a clinical trial on knee osteoarthritis during the last year
- Participation in any clinical trial completed less than 3 months ago
- Patient whose mental state does not allow him to understand the nature, objectives and possible consequences of the study
- Patient under legal protection (curatorship or guardianship)
- Pregnant woman or planning to become pregnant during the study or breastfeeding
Sites / Locations
- Florent Eymard
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PRP group
Placebo group
PRP will be prepared with The Regenkit BCT kit provided by the RegenLab laboratory. This is a 2B medical device with the CE mark. 5mL will be injected in knee under ultrasound guidance. The PRP extracted using this kit is poor in leukocytes, has a platelet concentration multiplied by 1.6 on average compared to circulating blood and is not activated (P2Bbeta according to the PAW classification; 3B according to the Mishra's classification).
5 mL of NaCl will be injected in knee under ultrasound guidance.