Genicular Artery Embolization for Reducing Pain in Medically Refractory Mild to Moderate Osteoarthritis: A Double-Blind, Randomized Sham-Controlled Pilot Study

PROJECT SUMMARY/ABSTRACT
Knee osteoarthritis (KOA) is a pervasive and debilitating disease, affecting over 15 million people in the US
alone. Symptoms include pain, stiffness, and ultimately loss of joint function. Medical therapies are the
mainstay of treatment as surgical joint replacement is typically reserved for advanced disease. Only half of
patients treated by medical management with disease not severe enough to warrant surgery experience
adequate pain relief, resulting in an estimated population of 3.6 million Americans who are left suffering.
Genicular artery embolization (GAE) is a novel, minimally invasive treatment that uses radiologic techniques to
catheterize pathologically hyperemic genicular arteries using live X-ray guidance with subsequent occlusion of
these vessels using injected microspheres. GAE is performed to inhibit or blunt synovial inflammation thought
to be a primary phenotype of KOA. While initial GAE studies have shown to significantly reduce pain
associated with KOA, these studies do not account for the greater than 40% placebo effect known to occur
with KOA treatments. A sham-controlled study is therefore central to validating the efficacy of this procedure.
Prior to performing this pivotal trial, we propose to conduct a pilot sham-controlled GAE study of 40 patients to
document feasibility of enrollment and understand the magnitude of effect between these two interventions for
future statistical power analysis. We also hope to establish MRI as an objective imaging biomarker for positive
remodeling of the knee that occurs after GAE due to decreased synovitis. If the results of this study are
positive, we plan to conduct a definitive sham-controlled study to justify the use of GAE in medically refractory
KOA and help provide a treatment option to the millions of people with this disease.

Grant Number: 7R21AR082123-02
NIH Institute/Center: NIH
Principal Investigator: Osman Ahmed