RecruitingPHASE3INTERVENTIONAL

Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2

The LipioJoint-2 study is investigating a new treatment for painful knee osteoarthritis called Genicular Arteries Embolization (GAE). Many people with this condition still experience significant pain despite trying usual treatments. GAE is a minimally invasive procedure, meaning it involves small cuts, that aims to relieve symptoms by safely blocking tiny blood vessels around the knee with a special oil. This study is testing how effective GAE is compared to a 'sham' procedure, which is like a dummy treatment, to ensure any benefits are real and not just from expectation. It's a large study, and participants will be between 40 and 90 years old. The goal is to find a new, effective way to help people with ongoing knee pain and improve their ability to move.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

130

Start

30 Sep 2024

Estimated completion

01 Oct 2028

Knee Osteoarthritis

What is this study about?

If you suffer from knee osteoarthritis, you know how much pain and difficulty moving it can cause. Often, standard treatments don't fully help everyone. This study, called LipioJoint-2, is exploring a new approach called Genicular Arteries Embolization, or GAE for short. Think of it like this: your painful knee has lots of tiny blood vessels. In GAE, a doctor uses a very thin tube to reach these tiny vessels and inject a special oil to block them off. The idea is that by reducing blood flow in these specific areas, we can reduce the pain signals coming from the knee.

This isn't the first time GAE has been studied. A previous smaller study, LipioJoint-1, suggested it was safe and showed promising signs that it could help with knee pain and movement. Now, LipioJoint-2 aims to get a clearer picture. To do this, some people will receive the GAE treatment, while others will have a 'sham' procedure. A sham procedure looks like the real thing but doesn't involve the actual treatment, which helps researchers figure out if the treatment itself is truly making a difference, or if other factors are at play.

The main goal of LipioJoint-2 is to confirm if GAE using this special oil is truly effective at reducing pain and improving how well your knee works. The study will carefully compare the two groups over a whole year to see if those who received GAE experience better and longer-lasting relief. This kind of research is really important for finding new ways to help people with ongoing knee pain when other options haven't worked well enough.

Key takeaways

This study is for people with painful knee osteoarthritis aged 40-90.
It tests a new treatment (GAE) to reduce knee pain using a special oil.
You might receive the GAE treatment or a sham procedure.
Participation involves screening, the procedure, and follow-up visits over 12 months.
The aim is to find out if GAE is a safe and effective way to relieve knee pain.

Who may be eligible?

This study is looking for people aged between 40 and 90 years old who have knee osteoarthritis that causes them pain. To be considered, your knee pain should be quite noticeable, and X-rays of your knee must show some evidence of osteoarthritis, but not necessarily very severe. You also need to have tried some treatment, like an injection into your knee, previously.

There are also some reasons why you wouldn't be able to join. For example, if you've recently had an injection into your knee, or if you've had knee surgery (apart from some specific ligament repairs). It's also not suitable if you have other types of inflammatory joint problems, or certain health conditions like severe kidney problems, certain heart conditions, or a known severe allergy to the oil or iodine used in the procedure. If you are pregnant or breastfeeding, or if you are already taking part in another study, you wouldn't be able to join this one. You also need to be able to understand French.

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 between 40 and 90 years old?
Do you have knee osteoarthritis causing pain?
Have you had an injection into the affected knee before?
Are you able to speak and understand French?
Have you not had a knee injection in the last 3 months?
Do you not have severe allergies to iodine or the oil used?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the LipioJoint-2 study, here's what to expect. First, you'll have a screening visit to see if you meet all the requirements. If you do, you'll have another visit with a specialist doctor who will explain the study in detail, and if you agree, you'll sign a consent form. Soon after, you'll have the main procedure, where you'll be randomly assigned to either receive the GAE treatment or a sham (dummy) procedure. During this procedure, you'll wear headphones or a special headset so you won't know which treatment you're getting.

After the procedure, you'll have follow-up visits or assessments at 1 month, 3 months, 6 months, and 12 months. At the 3-month visit, after you've completed some questionnaires about your pain and how your knee is functioning, you'll be told whether you received the GAE or the sham treatment. After this, you and your doctor can decide on the best ongoing care for your knee. The entire study participation would last for 12 months.

Potential risks and benefits

Taking part in this study could potentially offer you relief from your knee pain and improve your knee’s function, especially if you receive the actual GAE treatment and it proves effective. However, there are no guarantees, and it's also possible you could be in the sham group, meaning you wouldn’t get the active treatment in the study. Like any medical procedure, GAE carries some risks, such as allergic reactions to the oil or dye used, or issues related to accessing the blood vessels. The doctors will discuss all potential risks with you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (3)

Hôpital Saint Antoine - APHP
Verified postcode
Paris, France· Recruiting
Hôpital Cochin - APHP
Verified postcode
Paris, France· Recruiting
Hôpital européen Georges Pomidou - APHP
Verified postcode
Paris, France· Recruiting

Common questions

What is 'Knee Osteoarthritis'?

It's a common condition where the smooth cartilage covering the ends of bones in your knee gradually wears away, leading to pain, stiffness, and swelling.

What is 'Genicular Arteries Embolization (GAE)'?

It's a procedure where a doctor blocks tiny blood vessels around the knee with a special liquid to reduce pain signals from the joint.

What does 'sham procedure' mean?

A sham procedure looks just like the real treatment but doesn't involve the actual blocking of blood vessels. It helps researchers see if the real treatment truly works.

Will I know if I get the real treatment or the sham?

Not during the procedure or for the first three months. You'll find out which group you were in after completing some questionnaires at your 3-month follow-up.

How long will I be in the study?

Your participation in the study will last for a total of 12 months.

How to find out more

Touria EL AAMRI

touria.el-aamri@aphp.fr 0140271848 Official trial record

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