Abstract
Introduction: Cement extravasation during vertebroplasty (VP) is the most commonly reported complication. Cement viscosity is considered the single most important predictor of the risk of extravasation. Certainly, injecting high-viscosity cement (HVC) is difficult to utilize in real practice. We invented a new device capable of injecting high-viscosity with ease and at a distance to avoid radiation. The aim of this study is to confirm the efficacy and safety of the new device on cadaveric vertebrae.
Methodology: A 126 osteoporotic vertebral bodies were harvested from cadavers. Eighty vertebrae were included in the study. Computer-randomization software was used to allocate specimens over two main groups, Conventional VP and New Device. Both groups were further subdivided into two subgroups; high-viscosity and low-viscosity. A custom device was used on each vertebra to induce a compression fracture.
Results: Injecting HVC was associated with a lower leakage volume compared with low-viscosity cement. HVC was associated with no leakage into the spinal canal. It was also associated with a low incidence of vascular extravasation (P< 0.001). The mean volume of cement leakage in the low-viscosity group was 0.23 and 0.15 cc, for the Conventional VP and New Device, respectively. In both groups, the most common site for leakage was the vertebral end plate, which was exhibited more in the low-viscosity group (71.5%) compared with the high-viscosity group (42.5%). The preset target amount of cement to be injected was reached in 99% of the time when injecting HVC with the New Device, compared with 62% using the Conventional VP. In both groups, there was no correlation between the amount of cement injected and the amount of leakage.
Conclusion: The new device is capable of injecting HVC easily, with a lower incidence of cement leakage. It also minimized the risk of radiation exposure to the surgeon.