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LIPIOJOINT-2 : A randomized sham-controlled, double blind, multicenter trial on the effect of Genicular Arteries Embolization in symptomatic knee osteoarthritis
EU CTIS ID: 2023-508844-24-00
What this study is testing
Assess GAE efficacy using an ethiodized oil-based emulsion versus a sham procedure, by comparing the 3-months effect on knee pain in patients with symptomatic knee osteoarthritis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age 40 – 90 years
- · Previous intra-articular injection in the target knee
- • Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (4)
- • Radiographic Kellgren and Lawrence score ≥ 2 (5)
- • VAS pain score ≥ 40 mm (scale 0-100 mm)
- • 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
- • 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)
- • Prior ipsilateral partial or total knee replacement
See the full eligibility criteria
- • Age 40 – 90 years
- · Previous intra-articular injection in the target knee
- • Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (4)
- • Radiographic Kellgren and Lawrence score ≥ 2 (5)
- • VAS pain score ≥ 40 mm (scale 0-100 mm)
- • 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
- • 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)
- • Prior ipsilateral partial or total knee replacement
- • Any inflammatory joint disease other than osteoarthritis
- • Any contra-indication to puncture of the femoral artery
- • Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- • Regular intake of painkillers (except topical administration) for a pathology other than osteoarthritis
- • Ipsilateral symptomatic hip OA
- • Treated hyperthyroidism
- • Known severe allergy to Lipiodol® and/or iodine contrast medium
- • Known moderate to severe kidney failure (creatinine clearance < 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.