drugset / Trial / NCT03491761

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

NCT03491761

Phase 2 Recruiting 100 enrolled Endeavor Health
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-06-13
Primary completion
2025-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hyaluronic Acid Other / unclassified Other
Subject Platelet Rich Plasma Other / unclassified Other

Indications