Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., 2560 General Armistead Ave, Audubon, PA, 19403 USA.
Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., 2560 General Armistead Ave, Audubon, PA, 19403 USA.
Spine J. 2021 Dec;21(12):2097-2103. doi: 10.1016/j.spinee.2021.05.018. Epub 2021 May 23.
Osseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials.
The purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model.
In Vivo Preclinical Animal Study METHODS: Eighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively.
The 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm, 116.9±43.0 mm, and 108.7±15.2 mm, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05).
3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants.
Based on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.
骨整合是实现椎间融合刚性融合并最终获得成功临床结果的关键过程。3D 打印技术的进步允许常用的钛椎间融合器设计具有独特的结构，例如高度互联和特定的多孔结构，模仿小梁骨的结构。具有微尺度表面粗糙度和仿生多孔性的椎间植入物与传统材料相比，可能会促进骨的生长和长入。
本研究旨在使用体内绵羊模型比较由外科级聚醚醚酮（PEEK）、钛合金（TAV）和 3D 打印多孔仿生 TAV（3DP）组成的腰椎椎间融合装置的骨整合情况。
体内临床前动物研究
18 只绵羊进行了 2 级侧腰椎椎间融合术，随机分为 3DP、PEEK 或 TAV 椎间融合器（每个时间点每个融合器 6 个水平）。术后时间点为 6 周和 12 周。微计算机断层扫描和组织形态计量学用于定量测量植入物内的骨体积（BV）（长入）和表面骨附着比（BAR）（长入）。
在 6 周时，3DP 治疗组的 BV 明显高于 PEEK 和 TAV 组（77.3±44.1mm、116.9±43.0mm 和 108.7±15.2mm）（p<.05）。在 12 周时，各组之间没有 BV 差异（p>.05）。所有组的 BV 均从 6 周到 12 周时增加（p<.05）。在这两个时间点，3DP 治疗组（6w：23.6±10.9%；12w：36.5±10.9%）的 BAR 明显大于 PEEK（6w：8.6±2.1%；12w：14.0±5.0%）和 TAV（6w：6.0±5.7%；12w：4.1±3.3%）组（p<.05）。
与实心 PEEK 和 TAV 植入物相比，3DP 椎间融合器在 6 周时促进了更多的总骨长入，并且在术后 6 周和 12 周时促进了更多的骨长入。
基于这些发现，3DP 椎间融合器在椎间融合的各种临床应用中可能是传统 PEEK 和 TAV 椎间融合器的合理替代方案。
