NCT05378815

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	PRP injection	3 weekly intra-articular injections of 5mL PRP under ultrasound guidance
PROCEDURE	Placebo injection	3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-05-15
• Completion: 2028-02-15
• First posted: 2022-05-18
• Last updated: 2025-07-11

Locations

2 sites across 1 country: France