Informations générales (source: ClinicalTrials.gov)
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial (PIKOA)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2025
février 2028
10 mai 2025
Intro:
Platelet rich plasma (PRP) is largely used in various musculoskeletal disorders such as
chronic tendinopathies but also osteoarthritis (OA). Several therapeutic trials
evaluating the effectiveness of intra-articular PRP injections in knee OA as well as
meta-analyses have already been published. Most of them have compared PRP to Hyaluronic
Acid (HA). Their design was very heterogeneous in terms of PRP characteristics and
injection protocol. Moreover, the number of patients included was often very low. Only
few studies have compared PRP to placebo (physiological serum) and presented the same
methodological limitations (limited number of patients, heterogeneous protocols in terms
of number and frequency of injections, characteristics of PRP, etc.).
Given the insufficient level of evidence related to these limitations, PRP injections are
not recommended in the treatment of symptomatic knee OA by the main scientific societies
such as American College of Rheumatology (ACR), Osteoarthritis Research Society
International (OARSI), American Academy of Orthopedic Surgeons (AAOS) and French Society
of Rheumatology (SFR). Experts in the field agree on the need for a placebo-controlled
trial with hihg methodological quality and simple design in order to conclude with a good
level of evidence to the benefit or not of this new therapeutic weapon in symptomatic
knee osteoarthritis of moderate radiographic severity.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | EYMARD Florent | 18/04/2025 07:55:35 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | EYMARD Florent | 18/04/2025 07:55:35 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | EYMARD Florent | 18/04/2025 07:55:35 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Florent Eymard - 94010 - Créteil - France | Florent Eymard, MD,PHD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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