First-in-Human Evaluation of a New Resorbable Microspherical Embolic Agent for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteroarthritis.

Abstract

Purpose: To evaluate the safety and efficacy of Genicular Artery Embolization (GAE) using resorbable microspherical embolic agent to treat pain secondary to knee osteoarthritis.

Materials and methods: This prospective, single-arm, unblinded, first-in-human study was performed in 15 patients (12 women, mean age 62.8). GAE was performed with 200 ± 75mm resorbable alginate microspheres (SakuraBead; Crannmed, Galway, Ireland). Primary endpoint was safety, with efficacy evaluated as a secondary endpint using the pain Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 1, 3, and, 6 months. Adverse events were recorded at all timepoints.

Results: GAE was technically successful in all patients. There were six adverse events recorded in six different patients, all were minor and self-limiting (Grade 1). The percentage reduction in VAS, WOMAC Total and WOMAC Pain scores was calculated for individual patients. This showed there was a statistically significant reduction (p<0.001) in the mean VAS score of 76% , 77% and 63% at 1, 3 and 6 months respectively. There was a 78% reduction in WOMAC Total Score at both 1 and 3 months and 76% reduction at 6 months (P<0.01); this was accompanied by a reduction in WOMAC pain of 78%, 81% and 78% at 1, 3 and 6 months respectively (p<0.01).

Conclusions: In this limited pilot study, GAE using alginate resorbable microspheres was safe and produced significant improvement in pain and function in patients with KOA maintained to 6-month follow-up.