Status:
RECRUITING
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-79 years
Phase:
NA
Brief Summary
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 effective...
Detailed Description
Hypothesis/Objective: The main objective of this trial is to assess the pain decrease over the last 48 hours assessed by simple numerical scale (NRS) at W14 after 3 weekly injections of PRP (W0, W1 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05378815
Start Date
January 15 2025
End Date
February 15 2028
Last Update
July 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Henri Mondor
Créteil, Val-De-Marne, France, 94000
2
Florent Eymard
Créteil, France, 94010