Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Eligible age
40–90 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Assistance Publique - Hôpitaux de Paris
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT06497140 · last updated 2024-10-15