RecruitingNAINTERVENTIONAL

Genicular Artery Embolisation for Knee Osteoarthritis II

This study is investigating a treatment called Genicular Artery Embolisation (GAE) for people suffering from knee pain due to osteoarthritis. This is for those whose pain hasn't gotten better with usual treatments like physiotherapy. The aim is to see if GAE can reduce this pain. Participants will be split into two groups: one receiving the GAE treatment and another receiving a 'dummy' procedure (a saline injection). Neither the patients nor their doctors will know who received which treatment at first. After six months, those who had the dummy procedure will be offered the GAE treatment. The study plans to include up to 110 people aged 45 and over and will follow them for up to 24 months.

At a glance

Status

Recruiting

Phase

Sponsor

Varian, a Siemens Healthineers Company

Enrolment target

110

Start

30 Oct 2022

Estimated completion

30 Jun 2028

Knee Osteoarthritis

What is this study about?

If you're living with ongoing knee pain from osteoarthritis that hasn't improved with various treatments, this study might be of interest to you. It's designed to investigate a new approach called Genicular Artery Embolisation (GAE). Osteoarthritis can sometimes cause new, tiny blood vessels to grow around the knee, which some experts believe might contribute to pain. GAE aims to block these specific tiny blood vessels, potentially reducing your pain.

A key aspect of this research is comparing GAE to a 'sham' or dummy procedure. This is done to make sure that any improvements seen are truly due to the GAE treatment and not just a placebo effect (where people feel better because they expect to). You won't know whether you're receiving the actual GAE treatment or the dummy procedure, and neither will your doctors – this is called a 'double-blind' study. This method helps to get the most accurate results possible.

The study will follow participants for a significant period, up to 24 months. If you are initially in the dummy procedure group, you'll have the option to receive the GAE treatment after six months. This careful approach helps researchers understand the long-term effects and safety of the GAE treatment for knee osteoarthritis.

Key takeaways

This study explores a new treatment (GAE) for knee osteoarthritis pain.
It uses a 'double-blind' approach to ensure fair results.
Participants may receive GAE or a dummy procedure initially.
If you get the dummy procedure, you can still receive GAE after 6 months.
The study involves follow-up appointments over up to 24 months.
It's for people aged 45+ whose knee pain hasn’t responded to other treatments.

Who may be eligible?

To join this study, you generally need to be 45 years old or older and have mild to moderate knee osteoarthritis that has caused pain for at least three months. This pain should also be something that hasn't improved much with standard treatments like physiotherapy or injections. You should be able to lie flat comfortably for about six hours.

There are also some reasons why you might not be able to join. For example, if you have rheumatoid arthritis, very severe knee osteoarthritis, certain kidney problems, or issues with blood clotting, you might not be eligible. Also, if you need oxygen all the time, are pregnant, or have allergies to certain medical dyes or materials, you won't be able to take part. Researchers will check your medical history to make sure it's safe for you to participate.

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 45 years old or older?
Do you have knee pain from osteoarthritis that hasn't improved with other treatments for at least 3 months?
Can you lie flat comfortably for at least 6 hours?
Do you have mild to moderate knee osteoarthritis, not severe?
Are you able to provide your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a thorough check-up including a physical exam, a magnetic resonance imaging (MRI) scan of your knee, and some blood tests. You'll then be randomly assigned to one of two groups: either receiving the Genicular Artery Embolisation (GAE) procedure or a 'sham' (dummy) procedure which involves a saline injection.

Both procedures involve a small tube inserted through your groin. For GAE, tiny particles are delivered to block specific blood vessels in your knee, while the sham procedure involves a simple saline injection. You won't know which one you received. After the procedure, you'll have follow-up visits at 1 month, 3 months, and other regular times up to 24 months. At the 6-month mark, if you were in the sham group, you'll be offered the chance to have the GAE procedure. The total time you'll be followed by the study team will be up to 24 months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reduced knee pain if the Genicular Artery Embolisation (GAE) treatment proves effective. However, as with any medical procedure, there are potential risks, such as side effects from the procedure itself like bleeding or infection at the injection site, or allergic reactions to the materials used. You might also receive the dummy treatment first, which means waiting for the active treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Royal Berkshire NHS Foundation Trust
Verified postcode
Reading, United Kingdom· Recruiting

Common questions

What is Genicular Artery Embolisation (GAE)?

GAE is a procedure that aims to block tiny blood vessels around the knee that are thought to contribute to osteoarthritis pain.

What does 'double-blind' mean?

It means neither you nor your doctors will know if you received the GAE treatment or the dummy procedure. This helps make the study results more reliable.

What is a 'sham' procedure?

A sham procedure is a dummy treatment, in this case, a saline injection, designed to look and feel similar to the real procedure without delivering the active treatment.

What if I get the dummy treatment first?

If you're in the dummy treatment group, you'll be offered the actual GAE procedure after 6 months.

How long will I be involved in the study?

You'll be followed by the study team for up to 24 months in total.

How to find out more

Heike S Hausen, MD

heike.hausen@varian.com 2068903102 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.