Minimally invasive treatment for knee osteoarthritis pain
A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
This study is testing a new way to relieve knee pain for people with osteoarthritis by using a special treatment called Genicular Arteries Embolization to see if it helps them feel better and move easier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06497140 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Genicular Arteries Embolization (GAE) using an ethiodized oil-based emulsion to relieve pain in patients with symptomatic knee osteoarthritis. It is a multicenter, prospective, randomized sham-controlled trial, where patients will be randomly assigned to receive either the GAE treatment or a sham procedure. The study aims to assess pain relief and functional improvement over a 12-month follow-up period, with patients monitored through various questionnaires. The trial builds on previous findings that demonstrated the safety and potential efficacy of GAE in a smaller study.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary knee osteoarthritis who experience significant pain and are not eligible for knee surgery.
Not a fit: Patients who have had recent intra-articular injections or prior knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris and 2 other locations
- Hôpital Saint Antoine - APHP — Paris, France (Recruiting)
- Hôpital Cochin - APHP — Paris, France (Recruiting)
- Hôpital européen Georges Pomidou - APHP — Paris, France (Recruiting)
Study contacts
- Principal investigator: Marc SAPOVAL, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Touria EL AAMRI
- Email: touria.el-aamri@aphp.fr
- Phone: 0140271848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.