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

1 1 1 1

What is this study about?

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.

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.

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.

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).

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Cdozda Hjwhbizizrv Iignjfrksrnlu Lr Rhlwiqkpklamcducg Monfermeil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
07.06.2024

Trial locations

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.

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.

Trial ID:
2023-508844-24-00
NCT ID:
NCT06497140
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study comparing montelukast to placebo for reducing pain in patients with erosive osteoarthritis of the hands

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Portugal Spain
  • Efficacy of intra‑articular allogeneic peripheral blood mononuclear cells induced to an early apoptotic state versus placebo in adults with primary knee osteoarthritis

    Recruiting

    Denmark