Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis.

Abstract

PURPOSE\nTo assess the safety and efficacy of Genicular Artery Embolization (GAE) compared with a sham procedure in the treatment of knee pain secondary to mild-moderate grade Osteoarthritis (OA).\n\n\nMATERIALS AND METHODS\nA multicenter, single-blinded, randomized controlled trial was conducted to evaluate knee OA symptom reduction after GAE vs sham procedure. Subjects (n=21) with mild to moderate OA and intractable knee pain were randomized 2:1 to either GAE or a sham procedure. Subjects who were randomized to the sham procedure and did not report minimal clinical improvement in both total WOMAC and VAS scores were unblinded and able to crossover to treatment at 1 month. Longitudinal data were collected for 12 months, and subjects were excluded if they required additional analgesics at follow-up. Comparisons of reductions in VAS and Total WOMAC scores were performed using mixed effects linear regression models.\n\n\nRESULTS\nAll subjects in the sham group failed to show significant improvements at 1 month and crossed over to the treatment arm.There was a statistically significant greater pain reduction in treatment group vs sham at 1 month (50.1mm VAS; SE=10.6, 95% CI: [29.0, 72.3], p<0.01). Disability improvement was also significantly greater in the treatment group (24.7 points WOMAC; SE=10.4, 95% CI: [3.5, 45.9], p=0.02). Only minor adverse events were reported.5 subjects were excluded after increased analgesic use. Sensitivity analysis with all excluded patients confirmed significant improvements at 1 and 12 months.\n\n\nCONCLUSION\nIn patients with mild to moderate knee OA, GAE results in symptomatic improvement greater than sham procedure with clinically significant reduction in pain and disability.