Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Florent Eymard
NOT_YET_RECRUITING
Créteil
Henri Mondor
RECRUITING
Créteil
Contact Information
Primary
Florent Eymard, MD, PhD
florent.eymard@aphp.fr
01 49 81 27 02
Backup
Lila Kaci
lila.kaci@aphp.fr
01 49 81 36 24
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2028-02-15
Participants
Target number of participants: 210
Treatments
Experimental: PRP group
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).
Placebo_comparator: Placebo group
5 mL of NaCl will be injected in knee under ultrasound guidance.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov