Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Recruiting · NCT06497140 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
3 locations listed.
- Hôpital Saint Antoine - APHP - Paris, France
- Hôpital Cochin - APHP - Paris, France
- Hôpital européen Georges Pomidou - APHP - Paris, France