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New treatment option for Knee Osteoarthritis
Official title Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
ClinicalTrials.gov ID: NCT06497140
What this study is testing
What is Ethiodized Oil-based emulsion?
Ethiodized Oil-based emulsion is an investigational medicine, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Knee OsteoArthritis (KOA) is a common disease associated with pain and impaired function. Many patients are not relieved of their symptoms with enough efficacy by conservative treatments.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 90
You may be able to join if
- Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
- Radiographic Kellgren and Lawrence score ≥ 2 (6)
- VAS pain score ≥ 40 mm (scale 0-100 mm)
- Previous intra-articular injection in the target knee
- Patient not eligible to knee surgery
You likely can't join if
- Intra-articular injection of any product in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Any inflammatory joint disease other than osteoarthritis
- Any contra-indication to puncture of the ipsilateral femoral artery
- Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- Ipsilateral symptomatic hip OA
See the full eligibility criteria
- Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
- Radiographic Kellgren and Lawrence score ≥ 2 (6)
- VAS pain score ≥ 40 mm (scale 0-100 mm)
- Previous intra-articular injection in the target knee
- Patient not eligible to knee surgery
- For woman of childbearing potential: negative bêta-HCG before randomization
- Social security affiliation
- Signed informed consent
- Good understanding of the French language
- Intra-articular injection of any product in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Any inflammatory joint disease other than osteoarthritis
- Any contra-indication to puncture of the ipsilateral femoral artery
- Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- Ipsilateral symptomatic hip OA
- Treated hyperthyroidism
- Known severe allergy to Lipiodol® and/or iodine contrast medium
- Known moderate to severe kidney failure (creatinine clearance \< 30 45 ml/min)
- Known right-to-left cardiac shunt or intra-tumoral vascular shunt
- Asthma attack in the 8 days before randomization
- Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
- Symptomatic atheromatous lesion in the ipsilateral limb
- Patient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)
- Vulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)
- Patient under exclusion period in another trial
- Patient on AME (state medical aid)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.