Platelet-rich Plasma in Symptomatic Knee Osteoarthritis
France210 participantsStarted 2025-01-15
Plain-language 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 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.
Who can participate
Age range
40 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in global pain intensity in the target knee over the past 48 hours as assessed by Numeric Rating Scale (NRS) between week 0 and week 14