Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEndeavor Health

About this trial

This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.

Eligibility criteria

Qualifiers

Ability to provide informed consent

Chronic pain (>3 months)

Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)

Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain

Disqualifiers

Presence of major axial deformity (>5° valgus or varus deviation)

Surgery on target knee within 12 months prior to scheduled treatment

Autoimmune disorder

Active infections

Trial design

Treatments tested in this trial

  • PRP Treatment
  • HA Treatment

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators