Vertebral Body Stenting Versus Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures A Randomized Trial
Vertebral Body Stenting Versus Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures A Randomized Trial
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DOI：
10.2106/jbjs.l.00024
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发表时间：
2013-04-03
影响因子：
5.3
通讯作者：
Simmen, Hans-Peter
中科院分区：
文献类型：
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作者：
Werner, Clement M. L.;Osterhoff, Georg;Simmen, Hans-Peter
背景：在椎体压缩性骨折的治疗中，在应用骨水泥前插入可膨胀支架的椎体支架，以防止球囊后凸成形术患者出现椎体高度的继发性损失。本研究的目的是澄清球囊后凸成形术和椎体支架置入术在围手术期和术后的表现是否存在相关差异。方法：在一项双臂随机对照试验中，共100例新发生的骨质疏松性椎体压缩性骨折患者采用球囊后凸成形术治疗。椎体支架术。主要结果是介入后x线片上后凸角度的变化。次要结果是充气期间球囊压的最大压力、辐射暴露时间、围手术期并发症和水泥泄漏。结果：球囊后凸成形术后凸矫正角平均复位（标准差）为4.5°+/- 3.6°，椎体支架置入术后凸矫正角平均复位（标准差）为4.7°+/- 4.2°（p = 0.972）。椎体支架置入期间的平均压力为24 +/- 5 bar(348 +/- 72磅/平方英寸[psi])，球囊后凸成形术期间的平均压力为16 +/- 6 bar (233 +/- 81 psi) （p = 0.014）。辐射暴露时间无显著差异。所有患者均未接受翻修手术，未观察到术后神经系统后遗症。100个椎体节段中有25个发生骨水泥渗漏，两个干预组之间无显著差异（p = 0.230）。术中材料相关的并发症在球囊后凸成形术组的50个椎体节段中观察到1个，在椎体支架术组的50个节段中观察到9个。结论：在疼痛的骨质疏松性椎体骨折患者中，椎体支架置入术与球囊后凸成形术相比，在后凸矫正、骨水泥渗漏、辐射暴露时间或神经系统后遗症方面没有明显的效果。椎体支架置入与球囊充气过程中明显较高的压力和更多的材料相关并发症相关。
Background: In the treatment of vertebral compression fractures, vertebral body stenting with an expandable scaffold inserted before application of the bone cement was developed to impede secondary loss of vertebral height encountered in patients treated with balloon kyphoplasty. The purpose of this study was to clarify whether there are relevant differences between balloon kyphoplasty and vertebral body stenting with regard to perioperative and postoperative findings.Methods: In a two-armed randomized controlled trial, patients with a total of 100 fresh osteoporotic vertebral compression fractures were treated with either balloon kyphoplasty or. vertebral body stenting. The primary outcome was the post-interventional change in the kyphotic angle on radiographs. The secondary outcomes were the maximum pressure of the balloon tamp during inflation, radiation exposure time, perioperative complications, and cement leakage.Results: The mean reduction (and standard deviation) of kyphosis (the kyphotic correction angle) was 4.5 degrees +/- 3.6 degrees after balloon kyphoplasty and 4.7 degrees +/- 4.2 degrees after vertebral body stenting (p = 0.972). The mean pressures were 24 +/- 5 bar (348 +/- 72 pounds per square inch [psi]) during vertebral body stenting and 16 +/- 6 bar (233 +/- 81 psi) during balloon kyphoplasty (p = 0.014). There were no significant differences in radiation exposure time.None, of the patients underwent revision surgery, and postoperative neurologic sequelae were not observed. Cement leakage occurred at twenty-five of the 100 vertebral levels without significant differences between the two intervention arms (p = 0.230). Intraoperative material-related complications were observed at one of the fifty vertebral levels in the balloon kyphoplasty group and at nine of the fifty levels in the vertebral body stenting group.Conclusions: No beneficial effect of vertebral body stenting over balloon kyphoplasty was found among patients with painful osteoporotic vertebral fractures with regard to kyphotic correction, cement leakage, radiation exposure time, or neurologic sequelae. Vertebral body stenting was associated with significantly higher pressures during balloon inflation and more material-related complications.