Status:
RECRUITING
Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief 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 Ar...
Detailed Description
Patients will be screened during current practice consultation in each recruiting center (Screening Visit). When a patient will meet the eligibility criteria, he will be informed about the protocol. ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06497140
Start Date
September 30 2024
End Date
October 1 2028
Last Update
October 15 2024
Active Locations (3)
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1
Hôpital Saint Antoine - APHP
Paris, France, 75012
2
Hôpital Cochin - APHP
Paris, France, 75014
3
Hôpital européen Georges Pomidou - APHP
Paris, France, 75015