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

Abstract

Purpose: To assess the safety and efficacy of genicular artery embolization (GAE) compared with a sham procedure in the treatment of knee pain secondary to mild to moderate osteoarthritis (OA).

Materials and methods: A multicenter, single-blinded, randomized controlled trial was conducted to evaluate knee OA symptom reduction after GAE versus 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 clinical improvement in both the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analog scale (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. Reductions in the VAS and total WOMAC scores were compared using mixed-effects linear regression models.

Results: All subjects in the sham group failed to show significant improvements at 1 month and crossed over to the treatment arm. There was a statistically significantly greater pain reduction in the treatment group than in the sham group at 1 month (VAS, 50.1 mm; standard error [SE], 10.6; 95% confidence interval [CI], 29.0, 72.3; P<.01). Disability improvement was also significantly greater in the treatment group (WOMAC, 24.7 points; SE, 10.4; 95% CI, 3.5, 45.9; P=.02). Only minor adverse events were reported. Five subjects were excluded after increased analgesic use. Sensitivity analysis with all excluded patients confirmed significant improvements at 1 and 12 months.

Conclusion: In patients with mild to moderate knee OA, GAE results in symptomatic improvement greater than the sham procedure with clinically significant reduction in pain and disability.