Knee OsteoarthritisPIKOANCT05378815
Platelet-rich Plasma in Symptomatic Knee Osteoarthritis
A study testing PRP injection in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2025to 15 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Henri Mondor
Créteil, Val-De-Marne, 94000
- Not yet recruiting
Florent Eymard
Créteil, 94010
Florent Eymard, MD,PHD, 0149812702 ext. +33, florent.eymard@aphp.fr
About this study
Official title: Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
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.
Read the 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 and W2) compared to 3 injections of an equivalent volume of physiological serum in patients suffering from a knee osteoarthritis of moderate radiological severity [Kellgren and Lawrence (KL) 2 or 3].
The secondary objectives will aim to compare the decrease in the level of pain and functional assessed by NRS at W8 and W26, WOMAC scores at W8, W14 and W26, by OMERACT-OARSI response at W8, W14 and W26, in EQ5D-5L score at W8, W14 and W26 between PRN and placebo group. We will also assess the decrease in the consumption of analgesics at W8, W14 and W26 and the decrease in serum level of Coll2-1, Coll2-1 NO₂ and increase in PIIANP level at W8 and W14
- Conditions
- Knee Osteoarthritis
- Being tested
- PRP injection, Placebo injection
- Keywords
- Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionProcedure or surgery
3 weekly intra-articular injections of 5mL PRP under ultrasound guidance
Placebo injectionProcedure or surgery
3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | PRP will be prepared with A-CP-T-20 kit provided by the RegenLab laboratory. This is a 2B medical device with the CE mark. 5mL will be injected in knee under ultrasound guidance.
The PRP extracted using this kit is poor in leukocytes, has a platelet concentration multiplied by 1.6 on average compared to circulating blood and is not activated (P2Bbeta according to the PAW classification; 3B according to the Mishra's classification). Receives: Procedure: PRP injection |
| Placebo group | Placebo comparator | 5 mL of NaCl will be injected in knee under ultrasound guidance. Receives: Procedure: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between week 0 and week 14
Secondary outcomes (10)
Intensity of global pain in the target knee over the last 48 hours evaluated by NRS between week 0 and week 26
Measured: between week 0 and week 26
WOMAC score
The WOMAC score is a composite score widely used in international studies on knee osteoarthritis. This is a self-administered questionnaire comprising 3 sub-scores assessing pain (5 items), function (17 items) and stiffness (2 items). Each item is measured on a graduated scale from 0 to 100 (100 corresponding to the most severe symptoms). An average out of 100 will be calculated for each sub score and then for the total WOMAC score. The WOMAC score will be calculated before the first injection (W0) and at W8 and W14.
Measured: between week 0 and week 26
OMERACT-OARSI response
The OMERACT-OARSI response was developed by international scientific societies working on osteoarthritis in order to identify patients with a significant and clinically relevant response to a therapeutic strategy or to a given treatment. It is defined as either an improvement in the WOMAC pain score or the WOMAC score based on at least 50% and at least 20 points out of 100, or an improvement of at least 20% and at least 10 points out of 100 for 2 of the 3 following criteria: WOMAC pain score, WOMAC function score and overall assessment of symptoms by the patient (measured by graduated scale from 0 to 100). This response will be evaluated at W8 and W14.
Measured: between week 0 and week 26
EQ5D-5L score
The EQ5D-5L score is a composite quality of life score assessing 5 different areas (mobility, personal care, daily activities, pain, anxiety) and validated in osteoarthritis and chronic pain. Each item is measured on a scale of 1 (most favorable condition) to 5 (most unfavorable condition) depending on the severity of symptoms. The EQ5D-5L score will be calculated before the first injection (W0), at W8 and at W14.
Measured: between week 0 and week 26
Number of level 1 or 2 analgesics consumed
The consumption of analgesics will be evaluated at WO, W8, W14 and W26. The number and dose of level 1 or 2 analgesics consumed during the week preceding the visit will be noted (D-7 to D-2 before each assessment, patients not being authorized to take analgesics within 48 hours before the assessment). A notebook will be given to the patient so that he notes each analgesic taken with dosage and daily frequency.
Measured: between week 0 and week 26
drug dose of level 1 or 2 analgesics consumed
The consumption of analgesics will be evaluated at WO, W8, W14 and W26. The number and dose of level 1 or 2 analgesics consumed during the week preceding the visit will be noted (D-7 to D-2 before each assessment, patients not being authorized to take analgesics within 48 hours before the assessment). A notebook will be given to the patient so that he notes each analgesic taken with dosage and daily frequency.
Measured: between week 0 and week 26
Collection of adverse events
Measured: between week 0 and week 26
Serum biomarker assay Coll2-1
Measured: between week 0 and week 14
Serum biomarker assay Coll2-1 NO₂
Measured: between week 0 and week 14
Serum biomarker assay PIIANP
Measured: between week 0 and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start15 Jan 2025
- Primary completion15 May 2025
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double blinded, placebo-controlled trial comparing 3 intra-articular injections of PRP (Regenkit) and NaCl in patients with symptomatic knee osteoarthritis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Eymard, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378815
- Sponsor's protocol ID
- APHP200819
- Other IDs
- 2021-A00742-39
- Acronym
- PIKOA
- Status last verified
- Jul 2025
- First submitted
- 9 May 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eymard F, Oubaya N, Ornetti P, Sellam J, Richette P, Chevalier X; PIKOA study group. Protocol for a multicentre randomised triple-blind controlled trial assessing the clinical efficacy of intra-articular platelet-rich plasma injections versus placebo in symptomatic knee osteoarthritis (PIKOA). BMJ Open. 2024 Nov 29;14(11):e085025. doi: 10.1136/bmjopen-2024-085025.
PubMed 39615889
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
- ClinicalTrials.gov ID
- NCT05378815
- Acronym / sponsor ID
- PIKOA / APHP200819
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and W2) compared to 3 injections of an equivalent volume of physiological serum in patients suffering from a knee osteoarthritis of moderate radiological severity [Kellgren and Lawrence (KL) 2 or 3].
The secondary objectives will aim to compare the decrease in the level of pain and functional assessed by NRS at W8 and W26, WOMAC scores at W8, W14 and W26, by OMERACT-OARSI response at W8, W14 and W26, in EQ5D-5L score at W8, W14 and W26 between PRN and placebo group. We will also assess the decrease in the consumption of analgesics at W8, W14 and W26 and the decrease in serum level of Coll2-1, Coll2-1 NO₂ and increase in PIIANP level at W8 and W14
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blinded, placebo-controlled trial comparing 3 intra-articular injections of PRP (Regenkit) and NaCl in patients with symptomatic knee osteoarthritis
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Procedure: PRP injectionPRP will be prepared with A-CP-T-20 kit provided by the RegenLab laboratory. This is a 2B medical device with the CE mark. 5mL will be injected in knee under ultrasound guidance. The PRP extracted using this kit is poor in leukocytes, has a platelet concentration multiplied by 1.6 on average compared to circulating blood and is not activated (P2Bbeta according to the PAW classification; 3B according to the Mishra's classification). |
| Placebo group | Placebo comparator | Procedure: Placebo injection5 mL of NaCl will be injected in knee under ultrasound guidance. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injection3 weekly intra-articular injections of 5mL PRP under ultrasound guidance | Procedure or surgery | PRP group |
| Placebo injection3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance | Procedure or surgery | Placebo group |
Primary outcome
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
Time frame: between week 0 and week 14
10 secondary outcomes
Intensity of global pain in the target knee over the last 48 hours evaluated by NRS between week 0 and week 26
Time frame: between week 0 and week 26
WOMAC score
Time frame: between week 0 and week 26
OMERACT-OARSI response
Time frame: between week 0 and week 26
EQ5D-5L score
Time frame: between week 0 and week 26
Number of level 1 or 2 analgesics consumed
Time frame: between week 0 and week 26
drug dose of level 1 or 2 analgesics consumed
Time frame: between week 0 and week 26
Collection of adverse events
Time frame: between week 0 and week 26
Serum biomarker assay Coll2-1
Time frame: between week 0 and week 14
Serum biomarker assay Coll2-1 NO₂
Time frame: between week 0 and week 14
Serum biomarker assay PIIANP
Time frame: between week 0 and week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 39615889Eymard F, Oubaya N, Ornetti P, Sellam J, Richette P, Chevalier X; PIKOA study group. Protocol for a multicentre randomised triple-blind controlled trial assessing the clinical efficacy of intra-articular platelet-rich plasma injections versus placebo in symptomatic knee osteoarthritis (PIKOA). BMJ Open. 2024 Nov 29;14(11):e085025. doi: 10.1136/bmjopen-2024-085025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florent Eymard, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent Eymard, MD, PhD (01 49 81 27 02 ext. +33, florent.eymard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: between week 0 and week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.