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Embolization Agent

Genicular Artery Embolization for Osteoarthritis (GAE Trial)

N/A

Waitlist Available

Led By Osmanuddin Ahmed, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a procedure called genicular artery embolization (GAE) to help people with mild to moderate knee osteoarthritis. The procedure works by blocking small blood vessels around the knee to reduce pain and swelling. The study will measure how well this treatment works over time. Genicular artery embolization (GAE) is a novel treatment for knee osteoarthritis (OA) that has shown promising results in reducing pain and improving function by targeting abnormal blood vessels around the knee.

Who is the study for?

This trial is for people aged 40-80 with mild to moderate knee osteoarthritis (Grade 1-3) who've had pain for over 6 months despite trying NSAIDs, injections, exercise, or weight loss. It's not for those with severe arthritis (Grade 4), previous major knee surgery, active cancer/infection in the knee, recent steroid injections there, other joint diseases like rheumatoid arthritis, pregnancy, very low kidney function or platelet count.

What is being tested?

The study tests if a procedure called genicular artery embolization using Terumo Hydropearl® microspheres can reduce knee pain from osteoarthritis after one year. Success is measured by improvements in specific scores assessing pain and disability related to osteoarthritis.

What are the potential side effects?

Possible side effects may include discomfort at the injection site, allergic reaction to contrast material used during the procedure (if you're not already known to be allergic), and potential but rare complications related to catheter-based procedures such as bleeding or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

KOOS Scale

Oswestry Disability Index

WOMAC Scale

Secondary study objectives

KOOS for Knee Pain and Dysfunction

Opiate Usage

Oswestry Disability Index for Knee Pain and Dysfunction

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: GAE ArmExperimental Treatment1 Intervention

Patients who meet study eligibility will be scheduled to undergo the Genicular Artery Embolization procedure and will subsequent be followed for 12 months after their procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

the Terumo Hydropearl® microspheres device

2021

N/A

~10

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