Active not recruitingNAINTERVENTIONAL

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)

This research study is looking for people with ongoing knee pain due to osteoarthritis. It compares two ways to treat the pain: one is a newer procedure called Genicular Artery Embolization (GAE), which involves injecting tiny spheres (Embosphere Microspheres) into blood vessels around the knee. The other is a common treatment, steroid injections directly into the knee joint. The study aims to find out which treatment is more effective in relieving knee pain over a period of 24 months. It’s for adults whose knee pain hasn't improved with typical treatments. Your participation could help improve future care for knee osteoarthritis.

At a glance

Status

Active not recruiting

Phase

Sponsor

Merit Medical Systems, Inc.

Enrolment target

264

Start

16 Jan 2024

Estimated completion

01 Oct 2027

Knee Osteoarthritis

What is this study about?

If you're living with persistent knee pain from osteoarthritis, you might be interested in a new research study. This study is comparing two different approaches to ease this pain. One is a standard treatment you might already be familiar with: a steroid injection directly into the knee joint, which can help reduce inflammation and pain.

The other treatment being studied is called Genicular Artery Embolization (GAE). This is a newer procedure where tiny beads, called Embosphere Microspheres, are injected into small blood vessels around the knee. The idea is to reduce the blood flow to areas causing chronic inflammation and pain in the knee. By comparing these two treatments, researchers hope to understand which one offers better and longer-lasting relief for people struggling with knee osteoarthritis pain.

This study is important because it could help doctors and patients make better choices about how to manage knee osteoarthritis pain in the future, particularly for those whose pain hasn't improved with usual care. Participants will be randomly assigned to receive one of the two treatments, and doctors will carefully monitor their progress over two years.

Key takeaways

Compares a new knee pain procedure (GAE) with standard steroid injections.
Aims to find the most effective treatment for ongoing osteoarthritis knee pain.
Participation involves random assignment to one of two treatments.
Study lasts for 24 months with regular check-ups.
For adults aged 21+ with persistent knee pain not helped by other treatments.

Who may be eligible?

To join this study, you need to be at least 21 years old and have ongoing knee pain from osteoarthritis. Your pain should be mild to severe and haven't improved after at least three months of other treatments, like physical therapy or pain medications. The study is open to both men and women.

There are also some reasons why you might not be able to take part. For example, if you've already had a knee replacement on the knee causing you trouble, or if you have certain other medical conditions like advanced hardening of the arteries or certain types of arthritis (like rheumatoid arthritis or an infection-related arthritis). You also can't participate if you have a major surgery or blood vessel procedure planned within 30 days of the study's start.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 21 years or older?
Do you have mild to severe knee pain from osteoarthritis?
Has your knee pain not improved with other treatments for at least 3 months?
Have you NOT had a knee replacement on the painful knee?
Do you NOT have advanced hardening of the arteries or certain other types of arthritis?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first provide written permission to take part. After that, you'll be randomly assigned to receive either the Embosphere Microspheres procedure (GAE) or a standard steroid injection in your painful knee. You won't get to choose which treatment you receive. Over the next two years, you'll have several follow-up appointments where doctors will check your knee pain and overall well-being. These appointments will involve assessments to see how well the treatment is working for you. The total duration of your participation in the study will be 24 months.

Potential risks and benefits

Taking part in this study could potentially help reduce your knee pain and improve your quality of life, especially if the new GAE procedure proves more effective than current treatments. However, like all medical procedures, both treatments carry potential risks, such as bruising, infection, or discomfort at the injection site. The GAE procedure has its own specific risks, though these would be fully explained to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Memorial Care Long Beach Medical Center
Verified postcode
Long Beach, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States
Emory University School of Medicine
Verified postcode
Atlanta, United States
Biotech Clinical Research/ Georgia Vascular Institute
Verified postcode
College Park, United States
Northwestern University
Verified postcode
Chicago, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Saint Louis University
Verified postcode
St Louis, United States
Atlantic Medical Imaging
Verified postcode
Galloway, United States
Rutgers Health
Verified postcode
Newark, United States
Northwell Health
Verified postcode
Manhasset, United States
Weill Cornell Medicine
Verified postcode
New York, United States

Common questions

What is osteoarthritis?

Osteoarthritis is a common type of arthritis that happens when the protective cartilage on the ends of your bones wears down over time, leading to pain, stiffness, and swelling in the joints.

What are Embosphere Microspheres?

These are very tiny, spherical particles used in a procedure called GAE. They are injected into small blood vessels around the knee to help reduce inflammation and pain.

Will I know which treatment I'm getting?

No, you will be 'randomly assigned' to one of the treatments, meaning it's decided by chance, much like flipping a coin. This helps ensure the study results are fair.

How long will the study last for me?

If you join, you will be part of the study for a total of 24 months (two years).

What if my pain doesn't improve?

The study will closely monitor your pain. If the treatment isn't helping or your pain gets worse, the study doctors will discuss appropriate next steps for your care.