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RECRUITING
NCT03491761
PHASE2

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

Sponsor: Endeavor Health

View on ClinicalTrials.gov

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.

Official title: Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2018-06-13

Completion Date

2027-12

Last Updated

2024-02-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

PRP Treatment

PRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.

BIOLOGICAL

HA Treatment

Euflexxa will be used for treatment. It will be prepared according to the package insert.

Locations (1)

NorthShore University HealthSystems

Skokie, Illinois, United States