Safety and results of image-guided vertebroplasty with elastomeric polymer material (elastoplasty)

Abstract

Background: Image-guided elastoplasty is an innovative method for percutaneous vertebral augmentation with a silicone elastomeric material. Our aim was to evaluate its technical success, safety and efficacy as well as the rate of secondary fractures. Methods: Nineteen patients (13 women and 6 men, age 72 ± 10 years, mean ± standard deviation) underwent elastoplasty between 2010 and 2016. A total of 33 vertebrae were treated. A total of 2–6 mL of silicone-based elastomeric polymer material (VK100) was used. Visual analogue scale (VAS) and Oswestry disability index (ODI) pain scores were used. Results: In all cases, it was possible to complete the procedure (technical success 100%). No major complications occurred. In 6/19 (31.5%) patients, asymptomatic leakage of the material was observed during the procedure. Full pain recovery was obtained in 18/19 (94%) patients. One patient with a painful angioma did not experience any change in symptoms. VAS and ODI were significantly reduced after the procedure, from 7.9 ± 1.1 to 0.7 ± 1.4 and from 79.6 ± 12% to 9.9 ± 14% respectively (p < 0.001 for both comparisons). After vertebroplasty, 14 of 15 patients (93%) removed the brace and 16/19 (84%) completely stopped using any drugs for pain relief (p < 0.001 for both pre-procedure versus post-procedure comparisons). At a mean follow-up time of 26.5 ± 28.1 months (median 8.7 months, range 6–69 months), no secondary fracture occurred. Conclusion: Taking into consideration the relatively small sample size, image-guided elastoplasty seems to be a safe procedure providing effective pain control over time.