Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Platelet-rich Plasma (PRP) injections for treating knee osteoarthritis (OA), a condition that causes pain and stiffness in the knee. PRP is a treatment that uses components from your own blood to potentially help heal damaged tissues. The trial aims to compare the effectiveness of PRP injections to a placebo (a treatment with no active ingredients) in patients who have been experiencing knee pain for at least three months. The goal is to gather high-quality evidence to determine if PRP can be a helpful option for those suffering from moderate knee OA.

To participate in this trial, you must be between 40 and 79 years old and have knee OA that meets specific criteria, such as pain mainly in the knee joint and certain findings on X-rays. You also need to have not found relief from traditional pain treatments like over-the-counter pain relievers. Participants will receive clear instructions and will need to complete self-questionnaires during the study. It’s important to know that certain conditions, like other knee issues or recent surgeries, may prevent you from joining. Overall, this trial is a chance to contribute to important research that could improve treatment options for knee osteoarthritis in the future.

Gender

ALL

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 ≥ 40/100 (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 ≥ 40/100
• • 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