Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2

Summary

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. Genicular Arteries Embolization (GAE) is a new minimally invasive endovascular treatment allowing symptoms relief. The investigator previously demonstrated the safety of GAE using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a first-in-man single-arm clinical trial called LipioJoint-1 (clinicaltrials.gov: NCT04733092; EUDRACT: 2020-002206-10). This phase 1 study also provided encouraging evidence of GAE efficacy on knee pain and function. The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter, prospective, randomized sham-controlled clinical trial.

Eligibility

Inclusion 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

Exclusion Criteria:

* 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)

Conditions2

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