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评价聚醚醚酮(PEEK)-钛复合材料椎间融合器在羊腰椎体间融合模型中的应用:生物力学、微计算机断层扫描和组织学分析。

Evaluation of a polyetheretherketone (PEEK) titanium composite interbody spacer in an ovine lumbar interbody fusion model: biomechanical, microcomputed tomographic, and histologic analyses.

机构信息

Orthopaedic Bioengineering Research Laboratory, Department of Mechanical Engineering, Colorado State University, 1374 Campus Delivery, Fort Collins, CO 80523, USA.

Spine Fixation, Orthofix, Inc., 3451 Plano Parkway, Lewisville, TX 75056, USA.

出版信息

Spine J. 2017 Dec;17(12):1907-1916. doi: 10.1016/j.spinee.2017.06.034. Epub 2017 Jul 24.

Abstract

BACKGROUND CONTEXT

The most commonly used materials used for interbody cages are titanium metal and polymer polyetheretherketone (PEEK). Both of these materials have demonstrated good biocompatibility. A major disadvantage associated with solid titanium cages is their radiopacity, limiting the postoperative monitoring of spinal fusion via standard imaging modalities. However, PEEK is radiolucent, allowing for a temporal assessment of the fusion mass by clinicians. On the other hand, PEEK is hydrophobic, which can limit bony ingrowth. Although both PEEK and titanium have demonstrated clinical success in obtaining a solid spinal fusion, innovations are being developed to improve fusion rates and to create stronger constructs using hybrid additive manufacturing approaches by incorporating both materials into a single interbody device.

PURPOSE

The purpose of this study was to examine the interbody fusion characteristic of a PEEK Titanium Composite (PTC) cage for use in lumbar fusion.

STUDY DESIGN/SETTING: Thirty-four mature female sheep underwent two-level (L-L and L-L) interbody fusion using either a PEEK or a PTC cage (one of each per animal). Animals were sacrificed at 0, 8, 12, and 18 weeks post surgery.

MATERIALS AND METHODS

Post sacrifice, each surgically treated functional spinal unit underwent non-destructive kinematic testing, microcomputed tomography scanning, and histomorphometric analyses.

RESULTS

Relative to the standard PEEK cages, the PTC constructs demonstrated significant reductions in ranges of motion and a significant increase in stiffness. These biomechanical findings were reinforced by the presence of significantly more bone at the fusion site as well as ingrowth into the porous end plates.

CONCLUSIONS

Overall, the results indicate that PTC interbody devices could potentially lead to a more robust intervertebral fusion relative to a standard PEEK device in a clinical setting.

摘要

背景

用于椎间笼的最常用材料是钛金属和聚合物聚醚醚酮(PEEK)。这两种材料都表现出良好的生物相容性。与实心钛笼相关的一个主要缺点是其不透射线性,这限制了通过标准成像方式对脊柱融合术后的监测。然而,PEEK 是不透射线的,允许临床医生对融合质量进行临时评估。另一方面,PEEK 是疏水性的,这会限制骨向内生长。尽管 PEEK 和钛都在获得坚固的脊柱融合方面表现出了临床成功,但正在开发创新技术来提高融合率,并通过将这两种材料结合到单个椎间设备中,使用混合增材制造方法来创建更强的结构。

目的

本研究旨在检查用于腰椎融合的 PEEK 钛复合材料(PTC)笼的椎间融合特性。

研究设计/设置:34 只成熟雌性绵羊接受了两水平(L-L 和 L-L)椎间融合,使用 PEEK 或 PTC 笼(每只动物各一个)。动物在手术后 0、8、12 和 18 周时被处死。

材料和方法

死后,每个手术治疗的功能脊柱单元进行非破坏性运动学测试、微计算机断层扫描扫描和组织形态计量学分析。

结果

与标准 PEEK 笼相比,PTC 结构表现出运动范围显著减小和刚度显著增加。这些生物力学发现得到了融合部位骨量明显增加以及多孔终板内骨向内生长的证实。

结论

总体而言,结果表明,与标准 PEEK 装置相比,PTC 椎间装置在临床环境中可能导致更坚固的椎间融合。

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