Platelet-rich plasma for symptomatic knee osteoarthritis
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
NA · Assistance Publique - Hôpitaux de Paris · NCT05378815
This trial will test whether three weekly platelet-rich plasma (PRP) injections reduce knee pain more than placebo in adults 40–79 with moderate (KL 2–3) knee osteoarthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Créteil, Val-De-Marne and 1 other locations) |
| Trial ID | NCT05378815 on ClinicalTrials.gov |
What this trial studies
This is a placebo-controlled interventional trial comparing three intra-articular PRP injections (weeks 0, 1 and 2) with three matching injections of physiological serum. The main outcome is change in pain over the last 48 hours measured by numerical rating scale (NRS) at week 14, with additional pain and function assessments at weeks 8 and 26 and WOMAC scores at multiple time points. The trial also measures responder status by OMERACT-OARSI criteria, changes in analgesic use, and serum biomarkers (Coll2-1, Coll2-1 NO₂, PIIANP) at specified visits. Participants must have symptomatic femorotibial knee OA of moderate radiographic severity (KL 2–3) and meet other inclusion/exclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–79 with symptomatic knee osteoarthritis lasting more than three months, predominantly femorotibial pain, KL grade 2 or 3 on recent X-ray, an NRS pain score ≥40/100, and failure or contraindication to conventional analgesics or NSAIDs.
Not a fit: Patients with KL grade 1 or 4, predominant patellofemoral symptoms, other lower-limb conditions that interfere with assessment, or a symptomatic contralateral knee (NRS ≥40/100) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, PRP injections could provide greater and longer-lasting pain relief and improved function compared with placebo, potentially reducing the need for analgesics.
How similar studies have performed: Previous randomized trials and meta-analyses have suggested benefits of PRP versus hyaluronic acid, but few high-quality placebo-controlled trials exist and the placebo-controlled evidence is limited and heterogeneous.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil, Val-De-Marne and 1 other locations
- Henri Mondor — Créteil, Val-De-Marne, France (RECRUITING)
- Florent Eymard — Créteil, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Florent Eymard, MD, PhD
- Email: florent.eymard@aphp.fr
- Phone: 01 49 81 27 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial