Zhu Jia, Cui Yangyang, Shen Hangkai, Liao Zhenhua, Gu Hongsheng, Liu Weiqiang
Tsinghua Shenzhen International Graduate School, Tsinghua University, Shenzhen, China.
Department of Mechanical Engineering, Tsinghua University, Beijing, China.
PLoS One. 2025 Apr 29;20(4):e0317375. doi: 10.1371/journal.pone.0317375. eCollection 2025.
Zero-profile cage (ZPC) products have been widely used in anterior cervical decompression and fusion (ACDF) surgery. To develop a ZPC that meets the biomechanical requirements of the Chinese population, we designed a novel zero-profile cage (NZ) by analyzing the critical anatomical parameters of the cervical spine in healthy Chinese people. This study aims to investigate and assess whether the biomechanical properties of the newly designed NZ could satisfy the criteria for clinical application. The biomechanical properties of the NZ were evaluated by being implanted into cervical cadaveric specimens, measuring and analyzing the range of motion (ROM) of surgical segments. The experimental group in this study consisted of the NZ. As the control group, the gold standard product combination of ACDF surgery, anterior fixation plate combined with cage (P + C), and the FDA-approved ZPC product (Zero-P) were utilized. The experiment utilized six cadaveric specimens of human cervical vertebrae subjected to identical testing conditions. Following the completion of the test under intact conditions, fusion products were implanted into each specimen in segment C4-C5 in the following order: Zero-P, NZ, P + C. Biomechanical results revealed that the ROM of the surgical segment had decreased significantly under six basic working conditions following NZ implantation. Statistically significant differences were observed in the left bending (LB), right bending (RB), and left rotation (LR) conditions when compared to the intact conditions. The remaining working conditions did not exhibit a significant difference. However, the observed decreasing trend was consistent with previously documented research. In terms of the ROM of surgical segments, there was no statistically significant difference between the NZ group, the Zero-P group, and the P + C group. The biomechanical properties of the newly designed NZ in this study were superior, comparable to the fusion effect observed in conventional products of the Zero-P group and the P + C group. Furthermore, the biomechanical properties exhibited further improvement when subjected to LB and RB conditions. In the future, the newly designed NZ has great potential as a competitive choice for clinical applications.
零轮廓椎间融合器（ZPC）产品已广泛应用于颈椎前路减压融合术（ACDF）。为研发一款符合中国人群生物力学要求的ZPC，我们通过分析健康中国人颈椎的关键解剖参数，设计了一种新型零轮廓椎间融合器（NZ）。本研究旨在调查和评估新设计的NZ的生物力学性能是否能满足临床应用标准。通过将NZ植入颈椎尸体标本，测量并分析手术节段的活动范围（ROM），对NZ的生物力学性能进行评估。本研究的实验组由NZ组成。作为对照组，采用了ACDF手术的金标准产品组合，即前路固定板联合椎间融合器（P + C），以及美国食品药品监督管理局（FDA）批准的ZPC产品（Zero - P）。实验采用了六个在相同测试条件下的人体颈椎尸体标本。在完整条件下完成测试后，按照以下顺序将融合产品植入每个标本的C4 - C5节段：Zero - P、NZ、P + C。生物力学结果显示，植入NZ后，在六种基本工作条件下手术节段的ROM显著降低。与完整条件相比，在左侧弯曲（LB）、右侧弯曲（RB）和左旋（LR）条件下观察到统计学上的显著差异。其余工作条件未显示出显著差异。然而，观察到的下降趋势与先前记录的研究一致。在手术节段的ROM方面，NZ组、Zero - P组和P + C组之间没有统计学上的显著差异。本研究中新设计的NZ的生物力学性能优越，与Zero - P组和P + C组传统产品观察到的融合效果相当。此外，在LB和RB条件下，生物力学性能进一步改善。未来，新设计的NZ作为临床应用中有竞争力的选择具有巨大潜力。
