三维数字个性化手术设计在青少年特发性脊柱侧凸矫形手术中的应用

doi:10.3969/j.issn.2095-4344.1982

中国组织工程研究 ›› 2019, Vol. 23 ›› Issue (32): 5158-5163.doi: 10.3969/j.issn.2095-4344.1982

• 数字化骨科 digital orthopedics • 上一篇下一篇

三维数字个性化手术设计在青少年特发性脊柱侧凸矫形手术中的应用

付裕¹，张云凤²，苏宝科³，赵岩¹，辛大奇¹，王海燕³，许阳阳³，张聪⁴，王一丹³，王星³，高尚³，恩和³，蔡永强³，王建忠³，王志强³，高明杰³，李志军³，马界荣³，李筱贺³

内蒙古医科大学第二附属医院，¹脊柱外科，²影像科，内蒙古自治区呼和浩特市 010010；³内蒙古医科大学基础医学院人体解剖教研室，内蒙古自治区呼和浩特市 010010；⁴内蒙古医科大学第三临床教学医院，内蒙古自治区呼和浩特市 010010

出版日期:2019-11-18 发布日期:2019-11-18
通讯作者: 李筱贺，博士，教授，硕士生导师。内蒙古医科大学基础医学院人体解剖教研室，内蒙古自治区呼和浩特市 010010 李志军，硕士，教授，硕士生导师，内蒙古医科大学基础医学院人体解剖教研室，内蒙古自治区呼和浩特市 010010
作者简介:付裕，1979年生，男，汉族，博士，2015年重庆医科大学毕业，内蒙古自治区人，主任医师。并列第一作者：张云凤，1978年生，女，汉族，硕士， 2014年内蒙古医科大学毕业，内蒙古自治区人，副主任医师。
基金资助:
国家自然科学基金(81560348，81260269，81550042)，项目负责人：李志军|国家自然科学基金(81460330)，项目负责人：李筱贺|内蒙古自治区高等学校“青年科技英才计划”入选青年科技骨干(NJYT-15-B05)，项目负责人：李筱贺|内蒙古科技计划项目(2016)，项目负责人：李筱贺|内蒙古自然科学基金(2016MS08131)，项目负责人：李筱贺|内蒙古自治区科技创新引导项目(2017)|项目负责人：李筱贺|内蒙古人社厅归国留学人员基金，项目负责人：李筱贺

Application of three-dimensional digital operation planning to individualized adolescent idiopathic scoliosis surgery

Fu Yu¹, Zhang Yunfeng², Su Baoke³, Zhao Yan¹, Xin Daqi¹, Wang Haiyan³, Xu Yangyang³, Zhang Cong⁴, Wang Yidan³, Wang Xing³, Gao Shang³, En He³, Cai Yongqiang³, Wang Jianzhong³, Wang Zhiqiang³, Gao Mingjie ³, Li Zhijun³, Ma Jierong³, Li Xiaohe³

Online:2019-11-18 Published:2019-11-18
Contact: Li Xiaohe, MD, Professor, Master’s supervisor, Department of Human Anatomy, Basic Medical School, Inner Mongolia Medical University, Huhhot 010010, Inner Mongolia Autonomous Region, China Li Zhijun, Master, Professor, Master’s supervisor, Department of Human Anatomy, Basic Medical School, Inner Mongolia Medical University, Huhhot 010010, Inner Mongolia Autonomous Region, China
About author:Fu Yu, MD, Chief physician, Department of Spine, the Second Affiliated Hospital of Inner Mongolia Medical University, Huhhot 010010, Inner Mongolia Autonomous Region, China Zhang Yunfeng, Master, Associate chief physician, Department of CT Center, the Second Affiliated Hospital of Inner Mongolia Medical University, Huhhot 010010, Inner Mongolia Autonomous Region, China Fu Yu and Zhang Yunfeng contributed equally to this work.
Supported by:
the National Natural Science Foundation of China, No. 81560348, 81260269, 81550042 (to LZJ), No. 81460330 (to LXH)| the Youth Elite of Science and technology of Inner Mongolia Autonomous Region Colleges and Universities “Young Science and Technology Talents Program”, No. NJYT-15-B05 (to LXH)| the Inner Mongolia Autonomous Region Science and Technology Plan Project (2016) (to LXH)| the Natural Science Foundation of Inner Mongolia Autonomous Region, No. 2016MS08131 (to LXH)| the Science and Technology Innovation Leading Project of Inner Mongolia Autonomous Region (2017) (to LXH)| the Fund for Returnees from the Department of Human Resources and Social Security of Inner Mongolia Autonomous Region (to LXH)

摘要/Abstract

摘要：

文章快速阅读：

文题释义：

青少年特发性脊柱侧凸：青少年生长发育期间原因不清的脊柱侧凸称为特发性脊柱侧凸。

3D打印：即快速成型技术的一种，它是一种以数字模型文件为基础，运用粉末状金属或塑料等可黏合材料，通过逐层打印的方式来构造物体的技术。

摘要

背景：青少年特发性脊柱侧凸为青少年脊柱侧凸的最常见类型，畸形所导致的脊柱解剖学变化使得临床螺钉固定风险较高。

目的：针对青少年特发性脊柱侧凸患者建立数字化虚拟仿真手术设计方案。

方法：内蒙古医科大学第二附属医院脊柱外科收治的17岁青少年特发性脊柱侧凸患者1例行术前16排螺旋CT扫描，将CT资料利用Mimics 16.0软件进行三维重建，测量经椎弓根固定螺钉直径，长及固定角度后进行导航模板设计和3D打印，利用导航模板进行手术螺钉固定，术后CT扫描后评估置钉疗效。

结果与结论：对该位患者脊柱进行三维重建，利用软件逆向工程设计功能设计导航模板，使得固定螺钉避免穿透椎体前缘皮质和椎弓根内外侧皮质骨，对设计导航模板畸形3D打印，并利用其进行脊柱矫形手术矫形，术后评估，未见螺钉穿出皮质，置钉准确率达100%。结果证实，对于特发性脊柱侧凸患者利用三维数字化重建设计导航模板进行手术置钉具有较高置钉成功率。试验方案经已患者本人及家属知情同意并于2014年4月通过内蒙古医科大学伦理委员会审核，批准号：20140408。

ORCID: 0000-0003-2613-9740 (Fu Yu)
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 青少年特发性脊柱侧凸, 椎弓根固定, 椎弓根, 数字化三维重建, 导航模板, 3D打印

Abstract:

BACKGROUND: Adolescent idiopathic scoliosis is the most common form of scoliosis. Spinal anatomical changes caused by malformation make the risk of clinical screw fixation high.

OBJECTIVE: To investigate the method to establish a digital virtual surgery planning system for adolescent idiopathic scoliosis.

METHODS: One 17-year-old patient with adolescent idiopathic scoliosis was selected and underwent 16-slice spiral CT scan in Department of Spine, the Second Affiliated Hospital of Inner Mongolia Medical University. Three-dimensional reconstruction of CT data was conducted using Mimics 16.0 software. Navigation template design and three-dimensional printing were performed after measuring the diameter, length of transpedicular screw and angle after fixation. Surgical screw fixation was performed with navigation template, and the effect of screw placement was evaluated after CT scan.

RESULTS AND CONCLUSION: Three-dimensional reconstruction was conducted in the patient’s spine. Navigation templates were designed using software reverse engineering design function to prevent the screw from penetrating the anterior cortex of the vertebral body and the inner and outer cortical bone of the pedicle. Three-dimensional printing of deformity of navigation template was conducted and it was used in spinal orthopedic surgery. Postoperative evaluation showed that no screw penetrated the cortex and the accuracy of screw placement was 100%. The results showed that the successful rate of screw placement was high for patients with idiopathic scoliosis by using three-dimensional digital reconstruction design navigation template. The patient and her family member signed the informed consent. This study was approved by the Ethics Committee of Inner Mongolia Medical University in April 2014 (approval No. 20140408).

Key words: adolescent idiopathic scoliosis, pedicle fixation, pedicle, digital three-dimensional reconstruction, navigation template, 3D printing

中图分类号:

R459.9|R604|R605

付裕, 张云凤, 苏宝科, 赵岩, 辛大奇, 王海燕, 许阳阳, 张聪, 王一丹, 王星, 高尚, 恩和, 蔡永强, 王建忠, 王志强, 高明杰, 李志军, 马界荣, 李筱贺. 三维数字个性化手术设计在青少年特发性脊柱侧凸矫形手术中的应用[J]. 中国组织工程研究, 2019, 23(32): 5158-5163.

Fu Yu, Zhang Yunfeng, Su Baoke, Zhao Yan, Xin Daqi, Wang Haiyan, Xu Yangyang, Zhang Cong, Wang Yidan, Wang Xing, Gao Shang, En He, Cai Yongqiang, Wang Jianzhong, Wang Zhiqiang, Gao Mingjie, Li Zhijun, Ma Jierong, Li Xiaohe. Application of three-dimensional digital operation planning to individualized adolescent idiopathic scoliosis surgery[J]. Chinese Journal of Tissue Engineering Research, 2019, 23(32): 5158-5163.

图/表（结果） 1

Digital virtual visual reconstruction for AIS

The spine of the AIS patient could be reconstructed using the preoperative thoracolumbar thin-section CT scan data and 3D reconstruction software. The 3D morphology of the spine was clearly displayed, and could be observed from any angle as needed. The internal structure and boundaries of the bone were also clearly displayed after transparency processing (Figure 2).

Digital virtual visual planning for AIS

A screw placement plan was developed from three angles using the 3D rotation and transparency processing functions in the reverse engineering module of the 3D digital reconstruction software. Comprehensive virtual operation planning was achieved in the software (screw diameter, lateral angle, upward (downward) angle, and screw insertion length (screw path length) (Figure 6).

Postoperation follow-up

The success rate of screw placement in AIS patients was significantly improved with the development of the digital virtual operation planning system. Of the 24 thoracic pedicle screws placed according to the preoperative digital screw placement plan, 16 were grade I, and 6 were grade II and penetrated the lateral wall. No screws were grade III or IV. All screws met the placement requirements. No surrounding soft tissues and vital structures were damaged. The 6 screws that penetrated the lateral wall were all placed in accordance with the pedicle fixation method, and all penetrated the pedicle wall by less than 2 mm. The patient was followed up for 16 to 24 months. No screw loosening occurred, rendering a 100% success rate of screws placement (Figure 6).

Biocompatibility analysis

Since the use of screws was an existing long-term clinically used production-licensed product, its adverse reactions and biocompatibility were in line with clinical studies, and no related adverse reactions had been reported.

参考文献

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引言

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis, with the highest incidence of 2.5-4.5%^[1-4]. However, surgical fixation is difficult to achieve, due to the imbalanced development of different segments of the human spinal pedicle (with a large difference in pedicle size between segments), especially the small upper and middle thoracic pedicle diameters, or because of the immature spine development in adolescents, or pedicle distortion in patients with scoliosis. Specifically, there is often no suitable screw for placement, or screw placement leads to damage to the spinal cord and spinal nerve, resulting in serious malpractice. Therefore, this area is at high risk for surgery^[5-6], and allows a significantly increased safe angle for screw placement. However, it was found in the preliminary clinical application that the screw diameter not only had to meet the transverse diameter requirement of the pedicle-rib unit, but also the longitudinal diameter requirement. How to design or improve their shapes and functions to make them more suitable for scoliosis treatment, and how to apply them to human body have become the hotspots and difficulties

in idiopathic scoliosis treatment^[8]. With the rapid development of computer, imaging, and mechanical engineering technologies, real anatomical data can be obtained, and operation planning can be improved by means of mechanical engineering three-dimensional (3D) reconstruction, reverse engineering, and CAD technology, thereby increasing the success rate of operation^[9]. However, there are still no relevant reports on the evaluation of the efficacy of digital navigation template screw in 17-year-old adolescents with idiopathic scoliosis. To further study the exact efficacy of navigation template in spinal orthopedics, one patient with idiopathic scoliosis was selected in this study for preoperative 3D digital operation planning and postoperative evaluation of screw placement, in order to provide new ideas for increasing the screw placement accuracy rate and reducing surgical risk.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

材料方法

Design

Imaging experiment.

Time and setting

It was completed in the Digital Medical Center of Inner Mongolia Medical University in June, 2018.

Patients

A 17-year-old female patient (163 cm, 52 kg) who visited the Department of Spine Surgery (Exclusion of other spinal disorders (congenital spina bifida, spinal trauma, tumors, and tuberculosis), the Second Affiliated Hospital of Inner Mongolia Medical University for AIS was selected.

All experiments were approved by the Ethics Committee of Inner Mongolia Medical University in April 2014 (approval No. 20140408). Informed consent was provided by the patient and her parents to volunteer as a research subject. Cobb angle of major thoracic scoliosis was 58°, and that of compensatory lumbar scoliosis was 32°. The scoliosis was classified as Lenke typeI, King type II, and PUMC type IIb. Risser sign was grade 3. The patient had no previous history of spinal trauma or surgery. Full-length standing anteroposterior and lateral radiographs and supine side-bending radiographs were taken. Spine and spinal cord abnormalities were excluded by whole-spine MRI. Finally, AIS was confirmed by the above imaging results as well as medical history.

CT scanner and computer

A 16-slice GE Medical System Brilliance CT scanner was used with the following scan parameters: slice thickness 1.0 mm, tube voltage 200 mA, voltage 120 kv, and scan range C7-S1. A total of 578 slices were scanned. Images were processed and stored in the CT workstation, and then saved in DICOM format on a removable hard disk.

An Acer Desktop PC (CPU: Intel E6600; CPU clock speed: 3.2 GHz; internal memory: 4 GB DDR3 1333 MHz; video memory: 1G; hard drive: 1T; 21.5” LCD screen; operating system: Windows XP) was used.

3D image analysis software

Mimics 16.01 software (Materialise, Belgium) was provided by the Digital Medical Center of Inner Mongolia Medical University.

Data output, import, and reconstruction

Images of each slice were analyzed and compared using the imaging workstation. Gray scale was adjusted in bone window. The resulting clear images were stored on the removable hard drive. Next, the images were imported from the removable hard drive into Mimics 16.01, and registered in anterior, posterior, left, and right directions. Bone tissues were displayed by setting the threshold. Bone tissue boundaries automatically identified by the software were added and removed by the Graphical Editing function. Cavities in the cancellous bone were filled. Finally, modified images of each slice were superimposed using the 3D reconstruction function to reconstruct the 3D images of T₁-T₁₂ vertebrae and the corresponding costal heads. In addition, the relevant parameters were measured using the 3D measurement tool of the software (Mimics16.0, University of Louvain, Belgien).

Screw modeling

The STL file of a vertebral screw (Weigao posterior thoracolumbar fixation system, provided by Shandong Weigao Orthopedic Device Company Limited; Figure 1) with a diameter of 5.0 mm and length 50.0 mm constructed in reverse engineering design software was imported into the model. 3D registration was performed by 3D rotation of thoracic pedicle-rib unit, and the bony model was transparentized. The screw position was then registered based on the boundary structure of the mask (Figure 1, Table 1).

Preoperative simulation design of screw diameter and 3D printing navigation template of screw in pedicle unit fixation for idiopathic scoliosis

The width at the narrowest point of pedicle in each fixed segment was measured via 3D rotation of a single vertebra to different angles. The measured width was the diameter of the selected screw. According to the measurement results, the parameters of screw diameter were designed, and the 3D vertebrae model was imported to simulate screw placement and observe whether the pedicle unit was penetrated and navigation templates of screw were printed by Dimension Elite (SD Co., USA).

Preoperative simulation design of screw length in pedicle fixation for idiopathic scoliosis

The direction of screw placement was adjusted via 3D rotation of a single vertebra to different angles, so that the axis of the screw was coincident with the axis of pedicle, and the leading edge of the screw reached, but not penetrated the cortex of anterior vertebral edge. The effective fixation length traveled by the screw was measured using the 3D measurement tool.

The direction of screw placement was adjusted via 3D rotation of a single vertebra to different angles, so that the axis of the screw was coincident with the axis of pedicle, and the leading edge of the screw reached, but not penetrated the cortex of anterior vertebral edge. As measured by the “Measure 3D distance” function, the angle between the screw axis and the sagittal plane was the lateral angle, and that to the horizontal plane was the upward (downward) angle (Figures 2-5).

Clinical operation

Preoperative individualized operation planning

Totally 24 screws were inserted into thoracic pedicles of T₁-T₁₂ with the assistance of preoperative 3D digital reconstruction: T₂ 1 screw, T₃ 1 screw, T₄ 2 screws, T₅ 1 screw, T₆ 1 screw, T₇ 2 screws, T₈2 screws, T₉ 2 screws, T₁₀ 2 screws, T₁₁ 2 screws,T₁₂2 screws, L₁ 2 screws, L₂ 2 screws and L₃ 2 screws.

Internal fixation devices and operation parameter

Two internal fixation systems were used: China Great Wall and Weigao pedicle screw systems. The diameter and length of screws were 3.5-10.0 mm and 20-100 mm, respectively (Table 2).

Operation procedure

Thoracolumbar thin-section scanning was performed using the 16-slice GE Medical System Brilliance CT scanner at a tube voltage of 200 mA, voltage of 120 kV, and thickness of 0.625 mm. Screws were placed according to the plan developed from 3D digital reconstruction simulation (including screw depth, lateral angle, screw diameter selection, and other parameters) and navigation template of screw.

Evaluation methods

The fixation process and intraoperative and postoperative symptoms were recorded. Four grades were defined according to the screw position^[10]: Grade I: the screw was completely within the pedicle; grade II: the screw penetrated the pedicle wall by < 2 mm; grade III: the screw penetrated the pedicle wall by ≥ 2 mm but < 4 mm; and grade IV: the screw penetrated the pedicle wall by ≥ 4 mm. Grades I, II, and II screws that penetrated from the lateral pedicle wall but entered into the vertebral body from the medial sternocostal joint were acceptable. Grade III screws that penetrated from the medial, upper, and lower pedicle walls and grade IV screws were unacceptable.

Main outcome

The number of cases of screw penetrating cortical bone was observed.

讨论

Although the pathogenesis of idiopathic scoliosis has been extensively studied, it has not been completely clarified. In addition to congenital factors, biomechanical changes in postnatal spine development also play an important role in the occurrence of this disease. Most researchers suggest that idiopathic scoliosis is the combined result of various pathogenic mechanisms. The present study contributes significantly to clarifying the occurrence, development and prognosis of scoliosis^[10-13]. New fixation implants and external braces play an important role in effective correction of idiopathic scoliosis^[14-16]. How to design or improve their shapes and functions to make them more suitable for scoliosis treatment, and how to apply them to human body have become the hotspots and difficulties in idiopathic scoliosis treatment. With the rapid development of computer, imaging, and mechanical engineering technologies, real anatomical data can be obtained, and fixation implants and external braces can be designed and improved by means of mechanical engineering 3D reconstruction, reverse engineering, and CAD technology, thereby increasing the success rate of operation. Moreover, different plans can be preclinically validated and continuously improved by biomechanical finite element analysis.

In thoracic pedicle-rib unit screw placement simulation with digital visual reconstruction, the positional relationship between the screw and the segments to be fixed can be registered from any angle via 3D positioning at the horizontal, coronal and sagittal planes, as well as 3D rotation and transparence processing. Further on, it allows observing whether the screws have penetrated the pedicle cortex and vertebral cortex from all angles, thus exactly reproducing the operative process. It provides a basic platform for comprehensive individualized screw placement planning and selection screw placement parameters, which has a positive significance for improving the medical skills of doctors and recovery of patients^[17].

In this study, a model that was consistent with the patient’s real parameters was developed by 3D reconstruction of preoperative scanning image data. An operation plan that was entirely consistent with the practical operative process was developed by using the CAD function of the software and by registration of the existing screw model. Operative problems that might arise were fully considered during the simulation. The exact screw placement position and angle were determined. The operative process was accurately reproduced via 3D simulation. Therefore, the operation plan developed in this study entirely meets the practical operation requirements. In previous studies, screws and their placement position were usually selected based on two-dimensional CT images, the data of which vary greatly from practical operation. Such studies, therefore, have a low reference value for clinical surgery. In addition, the results of this study preliminarily indicate that individualized 3D digital operation planning contributes significantly to improving the success rate of clinical surgery.

This study preliminarily discusses the general process and key issues in developing a digital virtual operation planning system for AIS. However, it is only a preliminary attempt to investigate digital reconstruction and its application in AIS. There is still a great difference between the virtual and real environments due to the lack of a large number of cases of clinical application. For example, soft tissues and blood vessels surrounding the bone structure, as well as the surgical field, cannot be realistically simulated. If the bone tissue reconstruction can be superimposed with soft tissue images obtained by subsequent MRI, the model will be closer to the real patients. Therefore, the classic pedicle pathway can only be replaced by the pedicle-rib unit fixation when it is difficult to guarantee that pedicle screws will be safely placed into the thoracic vertebrae, especially the upper and middle thoracic vertebrae^{[18, 19]}. This is also one of the research directions we plan to pursue in the next future.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

三维数字个性化手术设计在青少年特发性脊柱侧凸矫形手术中的应用

Application of three-dimensional digital operation planning to individualized adolescent idiopathic scoliosis surgery

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