Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis

What this study is about

The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve ablation (PNA). The main question\[s\] the study aims to answer are: * Does GAE or genicular nerve PNA result in OA symptom alleviation compared to sham procedure? * Are there molecular or imaging biomarkers that aid in predicting treatment response for GAE or genicular nerve PNA? Subjects (N=150) patients with knee OA, resistant to non-surgical treatment for at least 3 months will be randomized 1:1:1 to either after GAE, genicular nerve PNA or sham procedure. Clinical outcomes will be measured using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 11-point numerical rating scale (NRS) for pain completed at baseline, 1 month, 3 months, and 6 months and then every 6 months for either two years or until the time of total knee arthroplasty (TKA) surgery.

Who can join (things the study team will check)

✅ You may be able to join if…

• Age > 40 years
• Able to provide informed consent
• Knee pain due to osteoarthritis for at least 6 months
• Pain refractory to conservative therapies (oral medication, or physical therapy, or activity modification) for at least 3 months with a desire for TKA
• Candidate for TKA at Hotel Dieu Hospital Site
• Able to comply with all treatments and protocol follow-up visits

🚫 You may not be able to join if…

• Current local infection
• Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)
• Current use of systemic immunosuppression therapy
• Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain)
• Irreversible coagulopathy
• Renal dysfunction as defined by GFR (eGFR) of <30 obtained within the past 60 days
• Contraindication for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis)
• IV CT and/or MRI contrast allergy characterized by anaphylaxis or anaphylactoid reactions
• Pregnancy or women of childbearing potential not currently on a medically acceptable method of birth control

Where this trial is running

• Kingston Health Sciences Centre, Kingston, Ontario, Canada

Who to contact

David Clinkard, MD · 613-549-6666 · david.clinkard@kingstonhsc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06166628.