单级和多级3D打印非覆盖式颈椎融合手术模板的设计、制造与评估
Design, fabrication, and evaluation of single- and multi-level 3D-printed non-covering cervical spinal fusion surgery templates.
作者信息
Safahieh A H, Nazemi H, Arjmand N, Azimi P, Khalaf K
机构信息
Mechanical Engineering Department, Sharif University of Technology, Tehran, Iran.
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
出版信息
Front Bioeng Biotechnol. 2024 Jul 12;12:1416872. doi: 10.3389/fbioe.2024.1416872. eCollection 2024.
BACKGROUND
Cervical spinal fusion surgeries require accurate placement of the pedicle screws. Any misplacement/misalignment of these screws may lead to injuries to the spinal cord, arteries and other organs. Template guides have emerged as accurate and cost-effective tools for the safe and rapid insertions of pedicle screws.
QUESTIONS/PURPOSES: Novel patient-specific single- and multi-level non-covering templates for cervical pedicle screw insertions were designed, 3D-printed, and evaluated.
METHODS
CT scans of two patients were acquired to reconstruct their 3D spine model. Two sets of single-level (C3-C7) and multi-level (C4-C6) templates were designed and 3D-printed. Pedicle screws were inserted into the 3Dprinted vertebrae by free-hand and guided techniques. For single-level templates, a total of 40 screws (2 patients × 5 vertebrae × 2 methods × 2 screws) and for multi-level templates 24 screws (2 patients × 3 vertebrae × 2 methods × 2 screws) were inserted by an experienced surgeon. Postoperative CT images were acquired to measure the errors of the entry point, 3D angle, as well as axial and sagittal plane angles of the inserted screws as compared to the initial pre-surgery designs. Accuracy of free-hand and guided screw insertions, as well as those of the single- and multi-level guides, were also compared using paired t-tests.
RESULTS
Despite the minimal removal of soft tissues, the 3D-printed templates had acceptable stability on the vertebrae during drillings and their utilization led to statistically significant reductions in all error variables. The mean error of entry point decreased from 3.02 mm (free-hand) to 0.29 mm (guided) using the single-level templates and from 5.7 mm to 0.76 mm using the multi-level templates. The percentage reduction in mean of other error variables for, respectively, single- and multi-level templates were as follows: axial plane angle: 72% and 87%, sagittal plane angle: 56% and 78%, and 3D angle: 67% and 83%. The error variables for the multi-level templates generally exceeded those of the single-level templates. The use of single- and multi-level templates also considerably reduced the duration of pedicle screw placements.
CONCLUSION
The novel single- and multi-level non-covering templates are valuable tools for the accurate placement of cervical pedicle screws.
背景
颈椎融合手术需要精确放置椎弓根螺钉。这些螺钉的任何误置/错位都可能导致脊髓、动脉和其他器官损伤。模板导向器已成为安全、快速插入椎弓根螺钉的精确且经济高效的工具。
问题/目的：设计、3D打印并评估了用于颈椎椎弓根螺钉插入的新型患者特异性单节段和多节段非覆盖模板。
方法
获取两名患者的CT扫描图像以重建其三维脊柱模型。设计并3D打印了两组单节段（C3 - C7）和多节段（C4 - C6）模板。通过徒手和导向技术将椎弓根螺钉插入3D打印的椎体。对于单节段模板，由一名经验丰富的外科医生总共插入40枚螺钉（2名患者×5个椎体×2种方法×2枚螺钉），对于多节段模板插入24枚螺钉（2名患者×3个椎体×2种方法×2枚螺钉）。术后获取CT图像，以测量与术前初始设计相比，插入螺钉的进针点、三维角度以及轴向和矢状面角度的误差。还使用配对t检验比较了徒手和导向螺钉插入的准确性，以及单节段和多节段导向器的准确性。
结果
尽管软组织切除极少，但3D打印的模板在钻孔过程中在椎体上具有可接受的稳定性，并且其使用导致所有误差变量在统计学上显著降低。使用单节段模板时，进针点的平均误差从3.02毫米（徒手）降至0.29毫米（导向），使用多节段模板时从5.7毫米降至0.76毫米。单节段和多节段模板其他误差变量平均值的降低百分比分别如下：轴向平面角度：72%和87%，矢状平面角度：56%和78%，三维角度：67%和83%。多节段模板的误差变量通常超过单节段模板。使用单节段和多节段模板也显著缩短了椎弓根螺钉放置的时间。
结论
新型单节段和多节段非覆盖模板是精确放置颈椎椎弓根螺钉的有价值工具。
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