Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the safety and efficacy of transcatheter arterial embolization in patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA). Eligible participants will receive geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 24 months after GAE.

Inclusion Criteria:

• Knee pain resistant to conservative treatment for at least 9 months post TKA performed for knee OA, and
• Moderate to severe knee pain: pain VAS ≥40 mm, and
• Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaires are validated in English.

Exclusion Criteria:

• Active systemic or local knee infection or;
• Active malignancy or;
• Life expectancy less than 6 months or;
• Prior ipsilateral knee arthroscopic surgery or repeat TKA (within 9 months of screening) or;
• Ipsilateral knee intra-articular injection in the last 3 months or;
• Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus or;
• Pregnant during the study period or;
• Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure or;
• Body weight greater than 200 Kg or;
• Known history of severe contrast allergy to iodinated contrast resulting in anaphylaxis or;
• Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain) or;
• known avascular necrosis in the target knee or;
• Complications of TKA such as suspected or confirmed early loosening, ligamentous instability, reflex sympathetic dystrophy, polyethylene wear with or without particle disease (osteolysis), and large effusions (with or without hemarthrosis) or;
• Patient is enrolled in a different trial for treatment of knee pain post total knee arthroplasty (ipsilateral knee)