Genicular Artery Embolization Using Imipenem/Cilastatin vs. Microsphere for Knee Osteoarthritis (GAUCHO). 12-Month Clinical Results of a Single-blind Randomized Controlled Trial

PURPOSE: To compare the safety and clinical outcomes of genicular artery embolization (GAE) performed with permanent microspheres (PM) and imipenem/cilastatin (I/C) in patients with mild-to-moderate knee osteoarthritis. MATERIALS AND METHODS: In this IRB-approved prospective, randomized, single-center, single-blind trial, 60 patients with mild-to-moderate knee osteoarthritis were allocated to GAE with I/C (n = 30) or microspheres (n = 30). Clinical outcomes were assessed at baseline, 30 days, 90 days, and 365 days using Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Injury and Osteoarthritis Outcome Score (KOOS). RESULTS: Baseline characteristics were similar between groups, except for a higher rate of bilateral treatment in the microsphere group (56.6% vs. 30.0%, p = 0.037). Technical success was achieved in all procedures, with lower embolic volume in the microsphere group (p = 0.003). The mean volume of embolic was 1.5 ml in the microsphere group and 2.0 ml in the I/C group (p = 0.003). Between-group comparisons showed no significant differences in VAS at 30, 90, and 365 days (3.20 vs. 2.28, p = 0.102; 3.38 vs. 3.33, p = 0.931; and 3.95 vs. 3.88, p = 0.928), in WOMAC pain (6.25 vs. 4.83, p = 0.182; 8.11 vs. 6.00, p = 0.051; and 7.50 vs 6.27, p = 0.323), or in KOOS pain (63.59 vs. 72.12, p = 0.115; 56.58 vs. 67.14, p = 0.074; and 53.76 vs. 65.81, p = 0.081) for I/C versus microspheres, respectively. CONCLUSION: GAE using either I/C or microspheres is safe and effective, with significant clinical improvement over 12 months and no major differences in adverse events and pain outcomes between embolic agents.