Krüger Antonio, Oberkircher Ludwig, Figiel Jens, Floßdorf Felix, Bolzinger Florent, Noriega David C, Ruchholtz Steffen
Department of Trauma and Reconstructive Surgery Philipps University of Marburg, University Hospital Giessen and Marburg, Baldingerstrasse, 35043 Marburg, Germany.
Department of Trauma and Reconstructive Surgery Philipps University of Marburg, University Hospital Giessen and Marburg, Baldingerstrasse, 35043 Marburg, Germany.
Spine J. 2015 May 1;15(5):1092-8. doi: 10.1016/j.spinee.2013.06.094. Epub 2013 Nov 5.
The treatment of osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly during the past two decades. Balloon kyphoplasty was developed to restore vertebral height and improve sagittal alignment. Several studies have shown these theoretical improvements cannot be transferred universally to the clinical setting.
The aim of the current study is to evaluate two different procedures used for percutaneous augmentation of vertebral compression fractures with respect to height restoration: balloon kyphoplasty and SpineJack.
Twenty-four vertebral bodies of two intact, fresh human cadaveric spines (T6-L5; donor age, 70 years and 60 years; T-score -6.8 points and -6.3 points) were scanned using computed tomography (CT) and dissected into single vertebral bodies. Vertebral wedge compression fractures were created by a material testing machine (Universal testing machine, Instron 5566, Darmstadt, Germany). The axial load was increased continuously until the height of the anterior edge of the vertebral body was reduced by 40% of the initial measured values. After 15 minutes, the load was decreased manually to 100 N. After postfracture CT, the clamped vertebral bodies were placed in a custom-made loading frame with a preload of 100 N. Twelve vertebral bodies were treated using SpineJack (SJ; Vexim, Balma, France), the 12 remaining vertebral bodies were treated with balloon kyphoplasty (BKP; Kyphon, Medtronic, Sunnyvale, CA, USA). The load was maintained during the procedure until the cement set completely. Posttreatment CT was performed. Anterior, central, and posterior height as well as the Beck index were measured prefracture and postfracture as well as after treatment.
For anterior height restoration (BKP, 0.14±1.48 mm; SJ, 3.34±1.19 mm), central height restoration (BKP, 0.91±1.04 mm; SJ, 3.24±1.22 mm), and posterior restoration (BKP, 0.37±0.57 mm; SJ, 1.26±1.05), as well as the Beck index (BKP, 0.00±0.06 mm; SJ, 0.10±0.06), the values for the SpineJack group were significantly higher (p<.05) CONCLUSION: The protocols for creating wedge fractures and using the instrumentation under a constant preload of 100 N led to reproducible results and effects. The study showed that height restoration was significantly better in the SpineJack group compared with the balloon kyphoplasty group. The clinical implications include a better restoration of the sagittal balance of the spine and a reduction of the kyphotic deformity, which may relate to clinical outcome and the biological healing process.
在过去二十年中，经椎弓根注入骨水泥治疗骨质疏松性椎体压缩骨折的方法得到了显著发展。球囊后凸成形术旨在恢复椎体高度并改善矢状位对线。多项研究表明，这些理论上的改善并不能普遍应用于临床实践。
本研究旨在评估两种用于经皮椎体压缩骨折强化的不同手术方法在恢复椎体高度方面的效果：球囊后凸成形术和SpineJack。
使用计算机断层扫描（CT）对两具完整新鲜人尸体脊柱（T6-L5；供体年龄分别为70岁和60岁；T值分别为-6.8和-6.3）的24个椎体进行扫描，并将其解剖为单个椎体。通过材料试验机（万能试验机，Instron 5566，德国达姆施塔特）制造椎体楔形压缩骨折。轴向载荷持续增加，直至椎体前缘高度降低至初始测量值的40%。15分钟后，手动将载荷降至100N。骨折后CT扫描后，将夹紧的椎体置于定制加载框架中，预加载100N。12个椎体采用SpineJack（SJ；法国巴尔马Vexim公司）治疗，其余12个椎体采用球囊后凸成形术（BKP；美国加利福尼亚州森尼韦尔美敦力公司Kyphon）治疗。手术过程中保持载荷，直至骨水泥完全凝固。术后进行CT扫描。测量骨折前、骨折后及治疗后的椎体前缘、中央和后缘高度以及贝克指数。
在椎体前缘高度恢复方面（BKP，0.14±1.48mm；SJ，3.34±1.19mm）、中央高度恢复方面（BKP，0.91±1.04mm；SJ，3.24±1.22mm）、后缘恢复方面（BKP，0.37±0.57mm；SJ，1.26±1.05mm）以及贝克指数方面（BKP，0.00±0.06mm；SJ，0.10±0.06mm），SpineJack组的值显著更高（p<0.05）。结论：制造楔形骨折并在100N恒定预载荷下使用器械的方案产生了可重复的结果和效果。研究表明，与球囊后凸成形术组相比，SpineJack组在椎体高度恢复方面明显更好。其临床意义包括更好地恢复脊柱矢状平衡和减少后凸畸形，这可能与临床结果和生物愈合过程有关。
