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Viscosupplementation

Platelet-Rich Plasma vs Hyaluronic Acid for Osteoarthritis

Phase 2

Recruiting

Led By Jason L Koh, MD, MBA

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 75 years old

Chronic pain (>3 months)

Must not have

Active treatment for a malignancy

Active infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks, 6 months, and 12 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether platelet-rich plasma (PRP) is more effective than hyaluronic acid (HA) in treating knee osteoarthritis, as measured by changes in cartilage thickness and pain/function scores. Approximately 100 subjects will be treated at NorthShore University HealthSystem.

Who is the study for?

This trial is for adults aged 18-75 with chronic knee pain from osteoarthritis, graded 2-3 on the K-L scale. Participants must have had pain for over three months and score at least a 40 on the VAS for pain. They should be able to consent and pass a physical exam, blood tests including platelet count, CRP, and ESR.

What is being tested?

The study compares two treatments: PRP (platelet-rich plasma) and HA (hyaluronic acid), to see which is better at improving knee osteoarthritis symptoms. It's measured by MRI changes in cartilage thickness and improvements in pain/function via KOOS/WOMAC scores.

What are the potential side effects?

Potential side effects of PRP or HA injections can include temporary increased joint pain or swelling, bleeding or bruising at the injection site, allergic reactions, or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have been experiencing pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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I do not have any active infections.

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I have diabetes.

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I haven't had any infiltrative treatments in the last 3 weeks.

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I have an open wound on my knee.

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I am on blood thinner medication.

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My spine or major limb has a significant bend.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cartilage Thickness on MRI

Secondary study objectives

3. A will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRP TreatmentExperimental Treatment1 Intervention

PRP is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. The PRP is obtained from a maximum 16 cc sample of the patients' blood drawn at the time of treatment. Using sterile technique, the venous blood is transferred to a centrifuge and prepared by the centrifugation process for 5 minutes. 4-7 mL of PRP is transferred from the large outer syringe into the small inner syringe and injected within 30 minutes of being spun to negate the need of anticoagulants. The procedure will take approximately 20-30 minutes.

Group II: HA TreatmentActive Control1 Intervention

HA is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. Euflexxa will be prepared according to the package insert.

0 / 9Eligibility criteria met