RecruitingPhase 2NCT03491761

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

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


Sponsor

Endeavor Health

Enrollment

100 participants

Start Date

Jun 13, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of knee injections — platelet-rich plasma (PRP), made from the patient's own blood, and hyaluronic acid (HA), a lubricating gel — to see which is more effective at reducing pain, improving function, and preserving cartilage in people with knee osteoarthritis. Researchers will use MRI scans to measure cartilage thickness at baseline and at 12 months, and questionnaires to track pain and function over time. Adults aged 18 to 75 with moderate knee osteoarthritis (grade 2–3), significant pain (40+ on a 100-point scale), and normal blood counts are eligible — those with diabetes, autoimmune disorders, prior knee surgery in the last year, or who are pregnant are excluded. Participation involves receiving one knee injection and attending follow-up visits at 1, 3, 6, and 12 months after treatment, including one MRI scan at 6 and 12 months. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPRP 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.

BIOLOGICALHA 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

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NCT03491761


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