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Studies

Interventional Recruiting

NCT05378815 on ClinicalTrials.gov

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

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

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Enrollment: 210 (Estimated)
  • Study start: 2025-01-15 (Actual)
  • Primary completion: 2025-05-15 (Actual)
  • Study completion: 2028-02-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Randomised, double blinded, placebo-controlled trial comparing 3 intra-articular injections of PRP (Regenkit) and NaCl in patients with symptomatic knee osteoarthritis
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Procedure: PRP injection
  • Procedure: Placebo injection

Primary Outcome Measures

  • 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)

Countries

France

Locations and Investigators

  • Henri Mondor, Créteil, France (Recruiting)
  • Florent Eymard, Créteil, France (Not yet recruiting)
    • Florent Eymard, MD,PHD

Study Officials