Pilot Study of Genicular Artery Embolization to Reduce Pain in Adults with Knee Osteoarthritis

What this Trial Is About

Researchers are evaluating genicular artery embolization GAE as a treatment to reduce pain in people with symptomatic knee osteoarthritis KOA who have not responded well to other treatments. This pilot randomized sham-controlled study aims to assess the feasibility of enrolling participants and to detect differences in pain relief between GAE and a sham procedure at 3 months using the Knee injury and Osteoarthritis Outcome Score KOOS pain subscore. The study also explores how psychological factors, analgesic use, and knee joint conditions may affect pain relief from GAE. Participants will be randomly assigned to one of two groups the GAE group, where embolization is performed using a 31 emulsion of Lipiodol and Optiray to temporarily block blood flow in targeted knee arteries, or the sham group, where a similar procedure is done without embolization. The embolization effect lasts about 10 minutes and aims to stop blood flow in the affected vessels without harming surrounding tissues. Each group will have 20 participants. During the study, participants will undergo various assessments including pain and knee function scores KOOS, WOMAC, VAS at different times up to 12 months, imaging to evaluate knee inflammation and blood flow, and tracking of analgesic and corticosteroid use. The main outcome is pain reduction at 3 months. The study involves a randomized, triple-blinded design to ensure unbiased results, with follow-up evaluations to monitor safety and effectiveness over one year.

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis