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

PURPOSE: To evaluate the safety and effectiveness of genicular artery embolization (GAE) using an resorbable microspherical embolic agent to treat pain secondary to knee osteoarthritis (KOA).

MATERIALS AND

METHODS

This prospective, single-arm, unblinded, first-in-human study was performed in 15 patients (12 women; mean age, 62.8 years). GAE was performed with 200-μm (SD ± 75) resorbable alginate microspheres (SakuraBead; CrannMed, Galway, Ireland). The primary endpoint was safety, with effectiveness evaluated as a secondary endpoint using the visual analog scale (VAS) pain score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 1 month, 3 months, and 6 months. Adverse events were recorded at all timepoints.

RESULTS

GAE was technically successful in all patients. There were 6 adverse events recorded in 6 different patients; all were minor and self-limited (Grade 1). The percentage reduction in VAS, WOMAC total, and WOMAC pain scores was calculated for individual patients. This showed that there was a statistically significant reduction (P < .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 a 76% reduction at 6 months (P < .01); this was accompanied by a reduction in WOMAC pain score of 78%, 81%, and 78% at 1, 3, and 6 months, respectively (P < .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.