中国组织工程研究

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (53): 7973-7978.doi: 10.3969/j.issn.2095-4344.2016.53.010

• 骨与关节临床实践 clinical practice of the bone and joint • 上一篇    下一篇

3D打印模块辅助腰椎弓根微创置钉：自身对照、开放性、2年随访临床试验方案

余正希，陈宣煌，张国栋，陈 旭，吴长福，郑祖高，高小强，林海滨   

  1. 福建医科大学莆田学院附属医院教学医院，南方医科大学附属莆田医院，莆田学院附属医院骨科，福建省莆田市 351100
  • 修回日期:2016-11-11 出版日期:2016-12-23 发布日期:2016-12-23
  • 通讯作者: 陈宣煌，硕士，副主任医师，福建医科大学莆田学院附属医院教学医院，南方医科大学附属莆田医院，莆田学院附属医院骨科，福建省莆田市 351100
  • 作者简介:余正希，男，1987年生，汉族，福建省仙游县人，2016年福建医科大学毕业，硕士，医师。
  • 基金资助:

    福建省莆田学院科研基金项目(2016055)；福建省卫生和计划生育委员会医学创新课题(2012-CX-34)

3D-printed module-assisted minimally invasive lumbar pedicle screw placement: study protocol for a self-controlled, open-label clinical trial with 2-year follow-up

Yu Zheng-xi, Chen Xuan-huang, Zhang Guo-dong, Chen Xu, Wu Chang-fu, Zheng Zu-gao, Gao Xiao-qiang, Lin Hai-bin   

  1. Department of Orthopedics, Affiliated Hospital of Putian University, Teaching Hospital of Fujian Medical University; Affiliated Putian Hospital of Southern Medical University; Affiliated Hospital of Putian University, Putian 351100, Fujian Province, China
  • Revised:2016-11-11 Online:2016-12-23 Published:2016-12-23
  • Contact: Chen Xuan-huang, Master, Associate chief physician, Department of Orthopedics, Affiliated Hospital of Putian University, Teaching Hospital of Fujian Medical University; Affiliated Putian Hospital of Southern Medical University; Affiliated Hospital of Putian University, Putian 351100, Fujian Province, China
  • About author:Yu Zheng-xi, Master, Physician, Department of Orthopedics, Affiliated Hospital of Putian University, Teaching Hospital of Fujian Medical University; Affiliated Putian Hospital of Southern Medical University; Affiliated Hospital of Putian University, Putian 351100, Fujian Province, China
  • Supported by:

    the Scientific Research Fund of Putian University, China, No. 2016055; and a grant for the Medical Innovation Project of Fujian Provincial Health and Family Planning Commission in China, No. 2012-CX-34

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摘要：

文章快速阅读：


文题释义：
Quadrant技术：应用美国Sofamor Danek公司研制发明的Quadrant脊柱后路微创撑开手术系统(MASTTM QUADRANTTM可扩张管通道微创系统)进行手术操作，与椎间盘镜手术不同的是借助可扩张撑开的顺畅工作通道，提供更宽广的入路精确地到达手术区域，无需附加内窥镜，在直视下即可顺利实现过去只有传统开放手术才能完成的腰椎管减压、椎间植骨融合和椎体复位、椎弓根螺钉内固定等脊柱后路内固定融合手术要求的所有复杂操作。
Quadrant可扩张通道管系统：工作通道管分为左右两叶，可平行撑开达55 mm，下端可扩张达12 mm，以提供足够的基本脊柱微创手术操作空间，既可以进行微创椎间盘摘除(包括高度粘连等疑难病例)，也可以微创术式进行跨节段的脊柱植骨融合及内固定植入。
 
摘要
背景：微创椎弓根螺钉内固定可有效修复胸腰椎疾患，但手术要求术者有熟练的操作技巧，置钉准确，否则术后会出现螺钉脱落等不良反应。3D打印能够为患者制定合适的植入体，对手术修复过程进行准确的模拟，降低手术的难度和复杂性，使植入体与修复的匹配度达到最高。
目的：验证3D打印模块辅助腰椎弓根微创置钉能否实现手术的精准定位。
方法：研究为单中心、自身对照、开放性、2年随访临床试验方案，在中国福建省莆田市，莆田学院附属医院完成。采集36例腰椎内固定修复病例的术前腰椎薄层CT扫描数据，经Mimics软件数字化三维重建，预设螺钉通过椎弓根的理想钉道，根据钉道周围可剥离骨面解剖结构设计并3D打印带钉道的导航模块。患者手术时在Quadrant系统工作通道中以3D打印模块导引腰椎椎弓根螺钉置入，内固定后再次薄层CT扫描并三维重建。试验的主要观察指标为术中置钉的准确率，评价术前设计3D打印带钉道导航模块与术中实际置钉效果的一致性；试验的次要观察指标为术前和术后6，24个月的腰椎CT成像，手术时间、术中出血量、术中辐射暴露时间，术后6，24个月的不良反应发生率。目前试验的手术部分已完成，结果显示，手术时间(120.58±56.46) min，术中出血量为(136.83±40.62) mL，术中辐射暴露时间为(50±11) s。共置入螺钉186枚，置钉准确率为98%。试验于2016年11月16日在北美临床试验注册中心注册(NCT02970578)；试验经中国福建省莆田学院附属医院伦理委员会批准，研究方案内容符合世界医学会制定的《赫尔辛基宣言》的相关要求；参与试验患者对治疗方案和治疗过程均知情同意，并签署知情同意书，研究从2012年11至2015年11月已开始有患者入组，完成全部数据随访时间为2017年3月。
讨论：①试验旨在证实3D打印模块可以在脊柱微创管道系统中辅助腰椎椎弓根螺钉微创、精准置入的设想；②为3D打印模块辅助Quadrant系统微创通道进行腰椎手术修复提供客观的临床参考数据。

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
ORCID: 0000-0001-9441-3014(陈宣煌)

关键词: 骨科植入物, 脊柱植入物, 临床试验, 3D打印, 腰椎弓根螺钉, Quadrant系统, 微创, 不良反应

Abstract:

BACKGROUND: Minimally invasive pedicle screw fixation is an effective treatment for thoracolumbar diseases, but skilled operations are required during the internal fixation. If inaccurate implantation occurs, adverse reactions will appear postoperatively; for example, the implanted screw will fall off. 3D printing can manufacture a suitable implant for a patient, accurately simulate the repair process, and reduce the difficulty and complexity of the operation, aiming to produce an implant that is most suitable for repair surgery.

OBJECTIVE: To verify that precise localization during minimally invasive lumbar pedicle screw placement can be achieved with the assistance of a 3D-printed module.
METHODS: A single-center, self-controlled, open-label clinical study with 2-year follow-up was carried out at the Affiliated Hospital of Putian University, Putian, Fujian Province, China. Preoperative thin-layer CT data from 36 cases of lumbar spine fixation were collected and digitally reconstructed using Mimics software. An ideal channel for screw insertion via the vertebral pedicle was preset, and a 3D-printed navigation module with a screw channel was designed and printed based on the anatomical structures of the bone surface that could be stripped around the screw channel. Minimally invasive pedicle screw fixation was then navigated by the 3D-printed module using the Quadrant system. A thin-layer CT scan was used for postoperative three-dimensional reconstruction. The primary outcome measure was accurate rate of screw placement, which was used to assess whether the screw placement under navigation by the 3D-printed module achieved the desired results. Secondary outcome measures included lumbar CT results preoperatively, 6 and 24 months postoperatively, operation time, intraoperative blood loss, duration of radiation exposure, and incidence of adverse events at 6 and 24 months postoperatively. Some results from the completed surgery are given below: the time of operation, amount of bleeding and duration of radiation exposure were (120.58 ± 56.46) minutes, (136.83±40.62) mL, and (50±11) seconds, respectively. A total of 186 screws were inserted in the patients, with a 98% accuracy rate. This trial was registered at ClinicalTrials.gov (NCT02970578) on 16 November 2016. Approved by the Ethics Committee of Putian University, Fujian Province, China, the study protocol was performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.Written informed consent was obtained from all participants prior to the trial. Patient recruitment began at November 2012 and lasted until November 2015, and follow-up data collection will be accomplished until March 2017.
DISCUSSION: The study aims to test our hypothesis that a 3D-printed module is a valuable aid for screw localization in minimally invasive lumbar pedicle screw placement, providing clinical data for 3D-printed module-assisted minimally invasive lumbar surgery using the Quadrant system.
 

Key words: Tissue Engineering, Lumbar Vertebrae, Internal Fixators

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