| 吴研飞,马剑雄,代 菁,赵兴文,卢 斌,靳洪震,马信龙.双向可撑开型融合器的体外生物力学评价[J].中国脊柱脊髓杂志,2023,(7):644-650. |
| 双向可撑开型融合器的体外生物力学评价 |
| 中文关键词: 生物力学 脊柱 可撑开融合器 双向 |
| 中文摘要: |
| 【摘要】 目的：对自行研制的一种新型双向可撑开型融合器进行体外生物力学评价。方法：将20具新鲜小牛脊柱L3/4节段标本随机分为4组进行造模，分别为正常组（完整状态）、不稳组（髓核摘除组）、传统融合器组[置入传统子弹型聚醚醚酮（Polyether-ether-ketone，PEEK）融合器]和新型融合器组（置入自行研制的双向可撑开融合器），每组5具标本。利用MTS多自由度（脊柱运动）模拟测试系统在实验标本上施加400N预载荷，同时在前屈、后伸、左弯、右弯、左旋和右旋等方向依次施加8Nm载荷，测试各方向运动范围（range of motion，ROM）。另外选择20具新鲜小牛脊柱L3/4节段标本，其中10具进行融合器的沉陷实验，10具进行融合器的拔出实验，每种实验均分为传统融合器组和新型融合器组，分别置入融合器，采用Bose Electroforce动态力学测试系统进行测试，比较分析两种融合器在椎间隙内的稳定性。结果：不稳定组和传统融合器组与正常组比较，各方向ROM值明显升高，差异有统计学意义（P＜0.05）；新型融合器组与正常组比较，在后伸、左弯、左旋和右旋工况下ROM值升高，差异有统计学意义（P＜0.05）；传统融合器组、新型融合器组与不稳组比较，各方向ROM值明显降低，差异有统计学意义（P＜0.05）；新型融合器组在屈伸、左右弯、左旋工况下的ROM值较传统融合器组降低，差异有统计学意义（P＜0.05）。在沉陷实验中，双向可撑开融合器最大压缩载荷（2265.67±13.01N）明显高于PEEK融合器（1665.67±10.83N），差异有统计学意义（P＜0.05）；在拔出实验中，双向可撑开融合器拔出强度（759.87±15.17N）高于传统PEEK融合器（93.37±3.15N），差异有统计学意义（P＜0.05）。结论：单纯置入自行研制的新型双向可撑开融合器在屈伸、侧弯、左侧旋转方向上比传统PEEK椎间融合器具有更好的力学稳定性，且在抗移位能力和抗沉陷能力方面优于传统PEEK融合器，在力学性能上满足临床应用的需求。 |
In vitro biomechanical evaluation of a bi-directional expandable cage |
| 英文关键词:Biomechanical Spine Expandable Cage Bi-directional |
| 英文摘要: |
| 【Abstract】 Objectives: To perform an in vitro biomachanical evaluation of a self-developed bi-directional expandable fusion device. Methods: 20 fresh calf spines(L3/4) were randomly divided into 4 groups of 5 each and were modeled into normal group(intact), unstable group (discectomy), conventional fusion group[implantation of traditional posterior bullet-type Polyether-ether-ketone(PEEK) cage], and new fusion group(implantation of a self-developed bi-directional expandable cage). Using MTS multi-degree of freedom(spinal motion) simulation test system, 400N preload was applied on the experimental specimen, and at the same time 8Nm moment was also applied in the directions of flexion, extension, left bending, right bending, left rotation and right rotation, and the range of motion(ROM) in each direction was tested. Another 20 calf spines(L3/4) were selected, among which 10 were subjected to sink tests and 10 to pull-out tests, and each test was molded according to the conventional fusion group and the new fusion group respectively and tested using the Bose Electroforce dynamic mechanical testing system to compare and analyze the stability of the two kinds of fusion cages in the intervertebral space. Results: The unstable and conventional fusion groups showed significantly higher ROM values in all directions compared with the normal group, with statistically significant differences(P<0.05), and the new fusion group showed higher ROM values in extension, left bending, left rotation and right rotation working conditions compared with the normal group, with statistically significant differences(P<0.05). The ROM values in all directions were significantly lower in the conventional fusion group and new fusion group compared with unstable group, and the differences were statistically significant(P<0.05). The ROM values in the new fusion group were lower in flexion and extension, right and left bending, and left rotation conditions compared with the conventional fusion group, and the differences were statistically significant(P<0.05). In the sink test, the maximum compressive load of the bi-directional expandable cage(2265.67±13.01N) was significantly higher than that of the PEEK cage(1665.67±10.83N), and the difference was statistically significant(P<0.05); In the pull-out test, the pull-out strength of the bi-directional expandable cage(759.87±15.17N) was higher than that of the conventional PEEK cage(93.37±3.15N), and the difference was statistically significant(P<0.05). Conclusions: The newly self-developed bi-directional expandable cage has better mechanical stability than the conventional PEEK intervertebral cage under the conditions of flexion-extension, lateral bending, and left rotation, and is superior to the conventional PEEK cage in terms of anti-displacement ability and anti-sinkage ability, meeting the needs of clinical applications in terms of mechanical properties. |
| 投稿时间：2022-10-18 修订日期：2023-02-03 |
| DOI： |
| 基金项目:国家自然科学基金（编号：11772226、81871777、81572154） |
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