Actively Recruiting
Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-10-15
130
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary knee osteoarthritis according to American College of Rheumatology criteria
- Radiographic Kellgren and Lawrence score of 2 or higher
- Pain score of 40 mm or greater on a Visual Analogue Scale (0-100 mm)
- Previous intra-articular injection in the target knee
- Patient not eligible for knee surgery
- Negative beta-HCG test for women of childbearing potential before randomization
- Social security affiliation
- Signed informed consent
- Good understanding of the French language
You will not qualify if you...
- Intra-articular injection in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Any inflammatory joint disease other than osteoarthritis
- Contraindication to puncture of the same side femoral artery
- Current treatment with cyclosporine, tacrolimus, cisplatin, vancomycin, amphotericin B, or any aminoside
- Ipsilateral symptomatic hip osteoarthritis
- Treated hyperthyroidism
- Known severe allergy to Lipiodol�ae or iodine contrast medium
- Moderate to severe kidney failure (creatinine clearance less than 30-45 ml/min)
- Known right-to-left cardiac or intra-tumoral vascular shunt
- Asthma attack within 8 days before randomization
- Planned exploration or treatment with radioactive iodine within 1 month after randomization
- Symptomatic atheromatous lesion in the same side limb
- Unable or unwilling to comply with follow-up schedule
- Vulnerable populations such as pregnant or breastfeeding women, patients under guardianship or deprived of liberty
- Currently in exclusion period of another trial
- Patient receiving state medical aid (AME)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hôpital Saint Antoine - APHP
Paris, France, 75012
Actively Recruiting
2
Hôpital Cochin - APHP
Paris, France, 75014
Actively Recruiting
3
Hôpital européen Georges Pomidou - APHP
Paris, France, 75015
Actively Recruiting
Research Team
T
Touria EL AAMRI
CONTACT
C
Cléo BOURGEOIS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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