Informations générales (source: ClinicalTrials.gov)

NCT06497140 En recrutement IDF
A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
Interventional
  • Arthrose
  • Gonarthrose
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2024
octobre 2028
18 septembre 2025
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
GHI LE RAINCY MONTFERMEIL SAPOVAL Marc En recrutement IDF 25/10/2025 10:00:23  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 25/10/2025 10:00:22  Contacter
AP-HP - Hôpital Cochin
AP-HP - Hôpital Europeen Georges Pompidou
AP-HP - Hôpital Henri Mondor-Albert Chenevier
AP-HP - Hôpital Saint Antoine
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital européen Georges Pomidou - APHP - 75015 - Paris - France Marc SAPOVAL, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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)