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Study on the Effect of Genicular Arteries Embolization with Ioversol and Ethyl Esters of Iodised Fatty Acids in Patients with Symptomatic Knee Osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The treatment being tested is called Genicular Arteries Embolization (GAE), which involves using a special mixture of substances, including ioversol and ethyl esters of iodised fatty acids from poppyseed oil, to reduce blood flow to certain areas of the knee. This is done in the hope of reducing pain and improving knee function. The study will compare the effects of this treatment to a sham procedure, which is a fake treatment that looks like the real one but does not have any active ingredients.

The purpose of the study is to assess the effectiveness of GAE in reducing knee pain over a period of three months. Participants will receive either the GAE treatment or the sham procedure, and their pain levels will be monitored and compared. The study will also look at other aspects of knee health and overall well-being over a longer period, up to 12 months. This will help researchers understand if the treatment has lasting benefits and how it affects the quality of life for people with knee osteoarthritis.

Throughout the study, participants will have regular check-ups to monitor their progress and any changes in their condition. The study aims to provide valuable information on whether this new treatment can offer relief for those suffering from knee osteoarthritis, potentially leading to new options for managing this common and often painful condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, previous knee injections, and a diagnosis of knee osteoarthritis.
Informed consent is required, and a negative pregnancy test is necessary for women of childbearing potential.
Step 2
Randomization
Participants are randomly assigned to either the treatment group or the sham procedure group.
This process ensures that the study results are unbiased.
Step 3
Initial assessment
An initial assessment is conducted, including a Visual Analogue Scale (VAS) pain score, which measures pain on a scale from 0 (no pain) to 100 (worst possible pain).
Other assessments include the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Knee injury and Osteoarthritis Outcome Score (KOOS).
Step 4
Treatment or sham procedure
Participants in the treatment group receive Genicular Arteries Embolization (GAE) using an ethiodized oil-based emulsion.
Participants in the sham group undergo a procedure that mimics the treatment but does not include the active intervention.
Step 5
Follow-up assessments
Follow-up assessments occur at 1, 3, 6, and 12 months after randomization.
These assessments include changes in the VAS pain score, WOMAC, KOOS, and other health evaluations.
Step 6
Medication and treatment description
Descriptions of pain medication and non-pharmacological treatments are recorded at each follow-up point.
This information helps to understand the overall management of knee osteoarthritis symptoms.
Step 7
Final evaluation
The final evaluation includes a comprehensive review of all collected data to assess the effectiveness of the treatment.
The primary endpoint is the change in the VAS pain score from randomization to 3 months.

Who can join the trial?

10 criteria

Age between 40 and 90 years old
Have had a previous injection directly into the knee joint
Diagnosed with primary **Knee Osteoarthritis (KOA)**, which is a type of arthritis affecting the knee, according to specific guidelines
Have a **Kellgren and Lawrence score** of 2 or higher, which is a way to measure the severity of knee osteoarthritis using X-rays
Experience knee pain with a **VAS pain score** of 40 mm or more on a scale from 0 to 100 mm, where higher numbers mean more pain
Not eligible for knee surgery
If a woman can have children, she must have a negative **beta-HCG** test, which checks for pregnancy, before starting the study
Must have social security affiliation
Must sign a form agreeing to participate in the study
Must understand the French language well

Who cannot join the trial?

3 criteria

Patients who do not have knee osteoarthritis, which is a condition that affects the knee joint, causing pain and stiffness.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they may need special protection or care.

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Verified sites

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Centre Hospitalier Intercommunal Le Raincy-Monfermeil
Monfermeil, France
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Hopital Beaujon
Clichy, France

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Investigated drugs

Genicular Arteries Embolization (GAE)
is a procedure being studied for its potential to relieve knee pain in patients with symptomatic knee osteoarthritis. This therapy involves blocking certain blood vessels in the knee to reduce inflammation and pain. The trial aims to determine how effective this procedure is in improving knee pain over a period of three months.
Ethiodized Oil-Based Emulsion
is used in the trial as part of the Genicular Arteries Embolization procedure. This emulsion helps in the embolization process by blocking the targeted blood vessels in the knee, which may help in reducing pain and inflammation associated with knee osteoarthritis.

What is already known about the treatment

Ethiodized Oil-Based Emulsion – This medication is administered through an injection directly into the genicular arteries, which are blood vessels around the knee. It is currently being studied in clinical trials for its effectiveness in treating knee osteoarthritis, a condition characterized by joint pain and stiffness. The main therapeutic indication is to reduce knee pain in patients with symptomatic knee osteoarthritis. The mechanism of action involves blocking blood flow to certain areas of the knee, which may help reduce inflammation and pain. It is classified as an embolic agent, used in procedures to block blood vessels.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease that affects the cartilage in the knee. Over time, the cartilage wears down, leading to pain, swelling, and reduced movement in the joint. As the condition progresses, the bones may rub against each other, causing further pain and stiffness. This can result in difficulty performing everyday activities such as walking or climbing stairs. The disease often develops slowly and can worsen over time, affecting the quality of life. It is more common in older adults and can be influenced by factors such as weight, genetics, and previous joint injuries.