Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

NCT05378815 | Recruiting

• 2 other identifiers: APHP2008192021-A00742-39
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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 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

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Platelet rich plasma; PRP; Placebo controlled trial

Outcome Measures

Primary Outcomes (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

  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

  between week 0 and week 26

• WOMAC score

  between week 0 and week 26

• OMERACT-OARSI response

  between week 0 and week 26

• EQ5D-5L score

  between week 0 and week 26

• Number of level 1 or 2 analgesics consumed

  between week 0 and week 26

Study Arms (2)

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).

Procedure: PRP injection

Placebo group

PLACEBO COMPARATOR

5 mL of NaCl will be injected in knee under ultrasound guidance.

Procedure: Placebo injection

Interventions

PRP injection PROCEDURE

3 weekly intra-articular injections of 5mL PRP under ultrasound guidance

PRP group

Placebo injection PROCEDURE

3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance

Placebo group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Henri Mondor

Créteil, Val-De-Marne, 94000, France

RECRUITING

Florent Eymard

Créteil, 94010, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39615889 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Florent Eymard, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Florent Eymard, MD, PhD

CONTACT

01 49 81 27 02; florent.eymard@aphp.fr

Lila Kaci

CONTACT

01 49 81 36 24; lila.kaci@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this trial, the patient, the investigator performing the intra-articular injection and the investigator assessing the outcomes will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blinded, placebo-controlled trial comparing 3 intra-articular injections of PRP (Regenkit) and NaCl in patients with symptomatic knee osteoarthritis

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 18, 2022
• Study Start: January 15, 2025
• Primary Completion: May 15, 2025
• Study Completion (Estimated): February 15, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

FR (2)