Peppelman Walter C, Beutler William, Gordon Michael, Chintakunta Suresh R, O'Halloran Damien, Bucklen Brandon
*Pennsylvania Spine Institute, Harrisburg, PA †Newport Orthopedic Institutes, Newport Beach, CA ‡Globus Medical Inc., Audubon, PA.
Clin Spine Surg. 2017 Apr;30(3):E211-E218. doi: 10.1097/BSD.0000000000000076.
An in vitro biomechanical study.
The aim of this study was to determine the effect of an optional sleeve on height restoration and compare it with the fracture reduction achieved by a commercially available inflatable bone tamp under simulated physiological load (110 N).
Loss of reduction after bone tamp deflation before cement injection still remains a concern. The optional sleeve surrounds the bone tamp to help maintain height during the kyphoplasty procedure while filling the created cavity with bone cement on the contralateral side.
Eighteen osteoporotic vertebral bodies (VBs) (T11-L4) were alternately assigned to 1 of the 2 treatment groups: group A: KYPHON (Kyphon Inc.) and group B: AFFIRM with sleeve (Globus Medical Inc.). The VBs were compressed axially at a rate of 5 mm/min until compressed to 40% of the initial anterior height. The fractured VBs then underwent kyphoplasty with cement augmentation while still maintaining load (110 N). The augmented VBs were then recompressed and anterior VB height (mm) and wedge angle (degrees) were measured initially after mechanically creating an anterior wedge fracture, and after repairing the compression fracture. The effect of kyphoplasty on vertebral height, kyphotic angle, cement volumes, and inflation pressures were compared between the treatment groups. Failure load (N) data were compared between intact and repaired VBs.
Average percentage of lost VB height restored in group A was 30%, compared with 56% for group B. The mean changes in wedge angle were similar to those of vertebral height measurements. No significant difference in mean inflation pressures (group A: 175±37 psi; group B: 160±36 psi) were found between the 2 groups. Average percentage increase in failure load was 241% and 212% in groups A and B, respectively.
Some height restoration was observed using the commercially available bone tamp in fractured VBs under simulated physiological load. The use of an outer sleeve significantly enhanced height restoration compared with the inflatable bone tamp alone.
一项体外生物力学研究。
本研究旨在确定一种可选套筒对高度恢复的影响，并将其与市售可充气骨填充器在模拟生理负荷（110 N）下实现的骨折复位效果进行比较。
在注入骨水泥前骨填充器放气后复位丢失仍是一个问题。可选套筒围绕骨填充器，在椎体后凸成形术过程中帮助维持高度，同时在对侧用骨水泥填充所形成的腔隙。
将18个骨质疏松性椎体（T11 - L4）交替分配至2个治疗组中的1组：A组：KYPHON（Kyphon公司）；B组：带套筒的AFFIRM（Globus Medical公司）。椎体以5 mm/分钟的速率轴向压缩，直至压缩至初始前高度的40%。然后在保持负荷（110 N）的情况下，对骨折椎体进行骨水泥强化椎体后凸成形术。之后对强化后的椎体再次进行压缩，并在机械制造前楔形骨折后以及修复压缩骨折后，测量椎体前高度（mm）和楔形角（度）。比较治疗组之间椎体后凸成形术对椎体高度、后凸角、骨水泥体积和膨胀压力的影响。比较完整椎体和修复后椎体的破坏负荷（N）数据。
A组恢复的椎体高度丢失平均百分比为30%，而B组为56%。楔形角的平均变化与椎体高度测量结果相似。两组之间的平均膨胀压力无显著差异（A组：175±37 psi；B组：160±36 psi）。A组和B组破坏负荷的平均增加百分比分别为241%和212%。
在模拟生理负荷下，使用市售骨填充器可使骨折椎体有一定程度的高度恢复。与单独使用可充气骨填充器相比，使用外部套筒可显著增强高度恢复效果。
