Awwad Waleed, Baljoun Amna, Alabdulkarim Yasir, Algarni Abdulrahman D, Kim Chung-Hwan, Giannitsios Demitri, Beckman Lorne, Ouellet Jean, Steffen Thomas
Department of Orthopedic Surgery, King Saud University, Riyadh, Saudi Arabia.
Department of Orthopaedic Surgery, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.
J Craniovertebr Junction Spine. 2018 Apr-Jun;9(2):116-121. doi: 10.4103/jcvjs.JCVJS_143_17.
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.
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.
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 ( < 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.
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.
椎体成形术（VP）期间骨水泥渗漏是最常报道的并发症。骨水泥粘度被认为是渗漏风险的唯一最重要预测因素。当然，在实际操作中使用高粘度骨水泥（HVC）很困难。我们发明了一种能够轻松且远距离注射高粘度骨水泥以避免辐射的新装置。本研究的目的是在尸体椎体上证实该新装置的有效性和安全性。
从尸体上获取126个骨质疏松椎体。80个椎体纳入研究。使用计算机随机化软件将标本分为两个主要组，传统椎体成形术组和新装置组。两组再进一步细分为两个亚组：高粘度和低粘度。在每个椎体上使用定制装置诱导压缩性骨折。
与低粘度骨水泥相比，注射HVC时渗漏量更低。HVC未出现渗漏至椎管内的情况。其血管渗漏发生率也较低（<0.001）。低粘度组中，传统椎体成形术组和新装置组的骨水泥平均渗漏量分别为0.23和0.15立方厘米。在两组中，最常见的渗漏部位是椎体终板，低粘度组（71.5%）比高粘度组（42.5%）表现得更明显。使用新装置注射HVC时，99%的情况下达到了预设的骨水泥注射目标量，而使用传统椎体成形术时为62%。在两组中，注射的骨水泥量与渗漏量之间均无相关性。
新装置能够轻松注射HVC，骨水泥渗漏发生率更低。它还将外科医生的辐射暴露风险降至最低。
