RecruitingPhase 3NCT06497140

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

A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

130 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis

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

Min Age: 40 YearsMax Age: 90 Years

Inclusion Criteria9

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 Criteria17

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)