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3D打印联合椎弓根导向器辅助置钉技术在重度先天性脊柱侧凸中的应用

Application of the 3D Printing Combined with Pedicle Guider Technology in Severe Congenital Scoliosis

【作者】 罗明

【导师】 夏磊;

【作者基本信息】 郑州大学 , 外科学(骨科)(专业学位), 2018, 硕士

【摘要】 重度先天性脊柱侧凸(CS)是指主弯Cobb角在90°以上的一类由于椎体发育异常所致的脊柱畸形。因其常伴椎体高度旋转、椎弓根发育不良甚至缺如,术中采用传统的徒手置钉技术难度大、风险高,手术神经并发症远高于青少年特发性脊柱侧凸(AIS)。近年有学者利用CT下测量的椎弓根皮质骨和松质骨宽度将椎弓根分类,作为术前评估以指导术中椎弓根螺钉置入,且发现异常椎弓根中发生螺钉位置不当的概率显著高于正常椎弓根。目前CT下测量椎弓根分类标准不一,尚无统一标准下比较CS和AIS异常椎弓根的发生率和分布情况的研究。与此同时,为了提高置钉准确性,CT或O臂导航技术已经运用于脊柱矫形,但设备昂贵、术中射线暴露、操作复杂等不足限制了其临床推广。随着3D打印技术近年在骨科的兴起,椎弓根导向器(PG)辅助置钉技术开始在脊柱畸形领域尝试使用,但其对于重度CS的安全性和有效性有待进一步论证。首先我们采用回顾性对照的研究方法,在同一标准的CT测量方法和分型系统下,对比分析了未经手术治疗的CS和AIS异常椎弓根的发生率和分布情况。对比发现CS中异常椎弓根发生率显著高于AIS,且上胸椎、主弯Cobb角大于70°、凹侧椎弓根是CS中异常椎弓根的危险因素。然后我们采用前瞻性非随机对照的研究方法,对比分析了采用PG技术和徒手置钉技术对于重度CS手术中的置钉准确率、影像学参数、手术相关指标和围手术期并发症。结果表明3D打印联合PG技术可以显著提高置钉准确率,缩短手术时间和减少术中输血。该技术对于重度CS手术安全有效,值得临床推广。第一部分先天性脊柱侧凸与青少年特发性脊柱侧凸异常椎弓根发生率和分布的比较目的比较先天性脊柱侧凸(CS)与青少年特发性脊柱侧凸(AIS)异常椎弓根发生率和分布情况。方法回顾性分析2012年1月至2016年12月于我院行胸、腰椎CT扫描的CS和AIS患者,依据病因诊断分为CS组和AIS组。根据椎弓根最宽平面的最窄距离将椎弓根分为5种类型:A型:松质骨通道>4mm;B型:松质骨通道2-4mm;C型:松质骨通道<2mm且皮质骨通道≥2mm;D型:皮质骨通道<2mm且椎弓根存在;E型:椎弓根缺如。将B,C,D和E型定义为异常椎弓根。对比分析两组异常椎弓根发生率及分布情况。对CS组椎弓根依据性别、年龄、主弯Cobb角、凹侧或凸侧进行亚组分析以探寻其异常椎弓根的危险因素。结果CS组中39名病人共1326个椎弓根通过测量并分型,异常椎弓根发生率为64%(843/1326);AIS组中24名病人共816个椎弓根通过测量并分型,异常椎弓根发生率为56%(455/816)。CS组中异常椎弓根的发病率显著高于AIS组(P<0.001)。CS和AIS异常椎弓根主要分布于上胸椎和胸腰椎。对CS组的亚组分析表明:上胸椎、主弯Cobb角大于70°、凹侧椎弓根是其异常椎弓根的危险因素。结论CS的异常椎弓根发生率显著高于AIS。重度CS因异常椎弓根发生率更高,螺钉置入的难度也更大。第二部分3D打印联合椎弓根导向器辅助置钉技术在重度先天性脊柱侧凸术中安全性和有效性的评估目的评估3D脊柱模型打印联合椎弓根导向器(PG)在重度先天性脊柱侧凸(CS)术中辅助置钉的安全性和临床效果。方法对2016年1月至2017年12月于我院收治的重度CS手术病人,进行前瞻性非随机对照研究。依据病人及监护人是否采用3D打印联合椎弓根导向器(PG)辅助置钉技术分为PG组和常规组。PG组采用Mimics软件设计椎弓根导向器,并用3D打印技术制作出1:1比例的脊柱模型和椎弓根导向器,术中利用导向器辅助置钉。常规组采用徒手置钉技术。术后两组复查CT,依据螺钉突破椎弓根皮质情况分为0-3级以评价椎弓根螺钉置钉准确性。对比两组病人术前、术后影像学参数,术中相关数据和围手术期并发症情况。结果PG组纳入11例CS病人(女7;男4),平均年龄12.65岁,术前主弯Cobb角117.52°;常规组纳入15例CS病人(女8;男7),平均年龄13.36岁,术前主弯Cobb角104.46°,两组术前影像学参数无统计学差异。术前制备198枚椎弓根导向器,术中成功辅助置入螺钉193枚,辅助置钉成功率97.5%(193/198)。术后CT评价置钉准确性,PG组置钉准确率(0级和1级)为81.3%,显著高于常规组的68.4%(P=0.002)。PG组的手术时间(P=0.025)、置钉时间(P=0.001)、单枚螺钉置入时间(P=0.013)和术中输血量(P=0.005)均少于常规组;但其住院总时间(P=0.008)和术前等待时间(P<0.001)多于常规组。两组在术后影像学参数和置钉相关并发症发生率上无显著差异。结论3D脊柱模型打印联合椎弓根导向器辅助置钉技术对于重度CS的置钉准确率为81.3%,该技术对于重度CS手术安全、可靠,同时缩短手术时间,减少术中输血。该技术经济实用、操作直观易懂,值得临床推广。

【Abstract】 Severe congenital scoliosis(CS)refers to a type of spinal deformity caused by an abnormal vertebral body,with a major curvature Cobb angle above 90°.Because it is often accompanied by high vertebral rotation,pedicle dysplasia,or even lack of,the use of traditional freehand pedicle screw placement technique is difficult and risky,and surgical neurological complications are much higher than adolescent idiopathic scoliosis(AIS).In recent years,some scholars have used pedicle cortical bone and cancellous bone width measured by CT to classify the pedicle as a preoperative assessment to guide the placement of pedicle screws.It was found that the probability of improper screw placement in abnormal pedicles was significantly higher than that of normal pedicles.At present,the classification criteria for pedicles under CT are different.There is no study comparing the incidence and distribution of abnormal pedicles of CS and AIS under the same criteria.At the same time,in order to improve the accuracy of nail placement,CT or O-arm navigation technology has been applied to spinal correction,but the disadvantages of expensive equipment,intraoperative radiation exposure,and complicated operation limit its clinical promotion.With the rise of 3D printing technology in orthopedics in recent years,pedicle screw guide(PG)assisted screw placement technology is still in the trial stage in the field of spinal deformity,and its safety and effectiveness for severe CS need to be further demonstrated.First,we used a retrospective study to compare the incidence and distribution of abnormal pedicles of CS and AIS without surgery under the same standard CT measurement method and classification system.The incidence of abnormal pedicles in CS was significantly higher than that in AIS,and the upper thoracic spine,the major Cobb angle greater than 70°,and the concave pedicles were risk factors for abnormal pedicles in CS.Then we used a prospective,non-randomized controlled study to compare the PG technology and freehand technology for severe CS surgery with the placement accuracy,imaging parameters,surgery-related indicators,and perioperative complications.The results show that 3D printing combined with PG technology can significantly improve the accuracy of nail placement,shorten the operation time and reduce intraoperative blood transfusion.This technique is safe and effective for severe CS surgery and is worthy of clinical promotion.Part 1 The comparison of incidence and distribution of abnormal vertebral pedicle between congenital scoliosis and adolescent idiopathic scoliosisObjective To compare the incidence and distribution of abnormal vertebral pedicle between congenital scoliosis(CS)and adolescent idiopathic scoliosis(AIS).Methods Retrospective comparative study of patients in our hospital were performed,from January 2012 to December 2016,with CT scan of thoracic and lumbar spine.Patients were divided into CS group or AIS group according to the diagnosis.The vertebral pedicles were divided into five types from type A to type E according to the narrowest distance of the widest plane of the pedicle.Type B,C,D and E were defined as abnormal pedicles.The incidence and distribution of abnormal pedicles were compared and analyzed.Results In the CS group,39 patients with1326 pedicles were measured,and the incidence of abnormal vertebral pedicle was 64%(843/1326).In the AIS group,24 patients with 816 pedicles were measured,and the incidence of abnormal vertebral pedicle was 56%(455/816).The incidence of abnormal pedicle in the CS group was significantly higher than that in the AIS group(P < 0.001).The abnormal vertebral pedicles were mainly distributed in the upper thoracic vertebra and thoracolumbar vertebra.For the subgroup analysis in the CS group,the upper thoracic vertebra,Cobb Angle of major carve more than 70° and concave side pedicle were the risk factors of abnormal pedicles.Conclusions The incidence of abnormal vertebral pedicle in CS patients is significantly higher than that of AIS,and it was more difficult in pedicle screw placement in severe CS patients.Part 2 The safety and effectiveness evaluation of the 3D printing combined with pedicle guider technology in severe congenital scoliosisObjective To evaluate the safety and clinical efficacy of the 3D printing combined with pedicle guide(PG)technology in the treatment of severe congenital scoliosis(CS).Methods A prospective non-randomized controlled study was conducted on patients with severe CS who were admitted to our hospital from January 2016 to December 2017.The patients were divided into the PG group and the control group based on the willingness of patients and their guardians to use 3D printing combined with pedicle guide technology.In the PG group,Mimics software was used to design the pedicle guide and the 3D printer was used to print the spine model and the pedicle guide.The guide was used to assist the pedicle screw placement.The control group used the free hand technology.Two groups of patients underwent CT examination after surgery,and the accuracy of pedicle screw placement was evaluated on the basis of the status of screws breaking through the pedicle cortex.The preoperative and postoperative imaging parameters,intraoperative data,and perioperative complications were compared between the two groups.Results The PG group included 11 CS patients(female 7;male 4)with an average age of 12.65 years.The preoperative Cobb angle was 117.52°.The control group included 15 CS patients(female 8;male 7)with an average age of 13.36 years.The preoperative Cobb angle was 104.46°.There was no statistical difference in preoperative imaging parameters between the two groups.A total of 193 screws were successfully implanted with the help of 198 pedicle guides during surgery,and the success rate of screw placement was 97.5%(193/198).Postoperative CT was used to evaluate the pedicle screw placement accuracy,PG group placement accuracy(grade 0 and 1)was 81.3%,significantly higher than the 68.4% of the conventional group(P=0.002).The operative time(P=0.025),placement time(P=0.001),single screw insertion time(P=0.013)and intraoperative blood transfusion(P=0.005)were all lower in the PG group than in the conventional group;The total time(P=0.008)and preoperative waiting time(P<0.001)were more than the control group.There was no significant difference in postoperative imaging parameters and the incidence of screw-related complications between the two groups.Conclusions The 3D printing and pedicle guide technology is safe and reliable for severe CS.It effectively solves the difficult and high risk of screw implanting during surgery,shortens the operation time,and reduces intraoperative blood transfusion.This technology is economical and practical,intuitive and easy to understand,and worthy of clinical promotion.

  • 【网络出版投稿人】 郑州大学
  • 【网络出版年期】2019年 01期
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