Phase
Condition
Knee Injuries
Osteoarthritis
Treatment
Ethiodized Oil-based emulsion
Sham-operation
Clinical Study ID
Ages 40-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of primary KOA according to the classification of the American College ofRheumatology (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
Exclusion
Exclusion Criteria:
Intra-articular injection of any product in the target joint within 3 months beforeembolization
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 afterrandomization
Symptomatic atheromatous lesion in the ipsilateral limb
Patient unable or unwilling to comply with the follow-up schedule (at theinvestigator's discretion)
Vulnerable populations (such as pregnant or breastfeeding women, patient underguardianship curatorship, deprived of liberty)
Patient under exclusion period in another trial
Patient on AME (state medical aid)
Study Design
Study Description
Connect with a study center
Hôpital Cochin - APHP
Paris, 75014
FranceActive - Recruiting
Hôpital Saint Antoine - APHP
Paris, 75012
FranceActive - Recruiting
Hôpital européen Georges Pomidou - APHP
Paris, 75015
FranceActive - Recruiting
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