Actively Recruiting
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-11
210
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 79
- Symptomatic knee osteoarthritis according to ACR criteria lasting more than 3 months
- Predominantly femoro-tibial knee pain
- Kellgren and Lawrence (KL) grade 2 or 3 on femorotibial X-rays taken within the last 6 months
- Pain score (ENS) of 40/100 or higher, with or without usual analgesic treatments
- Failure or contraindication to conventional treatments such as analgesics or NSAIDs
- Ability to understand study requirements and provide informed consent
- Ability to read and understand written instructions
- Ability to complete self-questionnaires
- Use of effective contraception for premenopausal women
You will not qualify if you...
- Other lower limb conditions that interfere with knee osteoarthritis evaluation (e.g., symptomatic hip OA, lumbar pain)
- Symptomatic osteoarthritis in the opposite knee with pain score (NRS) 40/100 or higher
- Predominant patellofemoral symptoms
- Radiographic knee OA stage 1 or 4 on the Kellgren and Lawrence scale
- Predominant radiographic patellofemoral osteoarthritis
- History of knee surgery with implants in the target knee
- History of inflammatory or microcrystalline rheumatism
- History of fibromyalgia
- Morbid obesity with BMI over 40 kg/m2
- Current inflammatory flare with KOFUS score 7 or higher
- Use of opioids in the month before enrollment
- Refusal to stop NSAIDs and conventional analgesics 48 hours before study procedures
- History of infection in the target knee
- Presence of chondrocalcinosis on frontal knee X-ray
- Previous platelet-rich plasma injection in the target knee
- Injection of hyaluronic acid or corticosteroids in the target knee in the last 3 months
- History of bleeding disorders or use of curative dose anticoagulants
- Treatment with antiplatelet agents such as aspirin, clopidogrel, or dipyridamole
- Hematological disease in progress or remission less than 5 years
- Thrombocytopenia with platelet count less than 150,000
- Current chemotherapy or immunosuppressive treatment
- Infection at the time of enrollment
- Participation in another knee osteoarthritis clinical trial in the last year
- Participation in any clinical trial completed less than 3 months ago
- Mental incapacity to understand study nature and risks
- Legal protection status such as guardianship or curatorship
- Pregnant or breastfeeding women or planning pregnancy during the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Henri Mondor
Créteil, Val-De-Marne, France, 94000
Actively Recruiting
2
Florent Eymard
Créteil, France, 94010
Not Yet Recruiting
Research Team
F
Florent Eymard, MD, PhD
CONTACT
L
Lila Kaci
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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