【作者】 李超；

【导师】 刘新宇；

【作者基本信息】 山东大学 ， 外科学（骨外）（专业学位）， 2023， 硕士

【摘要】 研究背景:脊柱侧凸是一种脊柱常见的三维畸形,包括冠状位、矢状位和轴位上的序列异常,通常伴有不同程度的椎体旋转。在严重的情况下,这种疾病会影响患者的呼吸和运动等功能。后路椎弓根钉棒固定矫形手术已成为严重脊柱弯曲者(Cobb角>40°)、支具不能控制疾病快速进展者以及有神经压迫症状者的标准治疗方法。然而,由于椎体的旋转、椎弓根发育异常以及比正常情况下更复杂的三维结构使得脊柱侧凸矫形术中螺钉的置入具有一定的挑战性。这些问题也增加了螺钉误置的潜在风险,并导致相应的并发症,如血管、神经和胸膜损伤等。目前,徒手置钉技术仍是椎弓根螺钉植入的主要方法。研究发现,脊柱侧凸矫形术中徒手置入椎弓根螺钉的误置率可达1.5%-43%,总体平均穿孔率为20.3%。在脊柱侧凸矫形术中,即使预先确定椎弓根的轨迹,由于轴向旋转(尤其是在顶椎水平)其螺钉可能不能正确的植入椎弓根。为了提高椎弓根螺钉植入的准确性,已经开发了几种技术应用于脊柱外科,如计算机断层扫描(CT)导航辅助技术或机器人辅助技术。近年来,三维“C”型臂和“O”型臂作为术中CT导航系统应用于脊柱外科椎弓根螺钉的置入,其中“O”型臂导航提供了术中三维透视影像,其图像质量与多层螺旋CT相似,同时减少了计算机辅助手术所需的时间。但导航技术仍在一定程度上可能受到人为错误和外科医生操作的影响。随着计算机导航技术的发展,机器人辅助技术逐渐用于脊柱手术辅助置钉,从而降低螺钉误置的风险以及相关的并发症。骨科机器人在导航技术基础上增加了机械臂,使得椎弓根螺钉置钉更方便和精确。机器人技术自诞生以来一直在不断发展,其应相比于传统技术提高了置钉的准确性,减少了术中辐射暴露,缩短了手术时间。目前我国自主研发的天玑骨科机器人(北京天智航医疗科技股份有限公司)已成功开展应用。天玑骨科机器人的优势在于机器人与导航系统的结合,同时可以实时跟踪置钉位置和患者的呼吸运动,从而降低椎弓根螺钉误置的比率。然而,目前关于天玑机器人技术和导航引导技术在脊柱侧凸矫形术中应用的研究有限。此外,机器人辅助技术与导航引导技术在椎弓根螺钉置入的准确性及安全性的比较也需要进一步探究。目的:本研究分析对比机器人辅助下椎弓根螺钉置入与导航辅助下椎弓根螺钉置入在脊柱侧凸矫形手术中的准确性和安全性,并评价其临床应用价值。方法:回顾性分析2020年1月至2022年12月于山东大学齐鲁医院收治的66例接收矫形手术的脊柱侧凸患者的术前及术后随访的影像学资料以及临床疗效评分资料。32例采用机器人辅助下椎弓根螺钉置入术(机器人组),男6例,女26例,平均14.9±3.1岁,其中特发性脊柱侧凸23例,先天性脊柱侧凸7例,神经肌肉性脊柱侧凸2例。34例采用导航辅助下下椎弓根螺钉置入术(导航组),男7例,女27例,平均年龄15.3±2.9岁;其中特发性脊柱侧凸27例,先天性脊柱侧凸5例,神经肌肉性脊柱侧凸2例。本研究术中使用三维扫描评估第一次椎弓根螺钉置入的准确性、术后使用重建的CT图像数据来评估椎弓根螺钉置入的准确性。使用以下螺钉误置分级系统评估螺钉位置,分为4级:0级,CT显示椎弓根完全位于椎弓根及椎体内视为置入准确;1级,螺钉轻度穿透皮质≤2mm;2级,螺钉穿透皮质2.1～4mm或小于1个螺钉直径;3级,螺钉穿透皮质>4mm或>1个螺钉直径。0级和1级螺钉为临床可接受的准确置钉。记录手术时间、术中出血量、术中辐射剂量、术后住院时间和术后并发症。使用标准方案拍摄术前术后脊柱全长正侧位来测量术前及术后Cobb角。分别于术前、术后在CT图像上测量顶椎旋转角。术后在正位X线片上观察椎弓根螺钉与连接棒的位置来观察顶椎旋转分级:0级,双侧椎弓根螺钉尖部位于两连接棒内侧,椎体旋转>0且<9°;1级,一侧椎弓根螺钉的尖部被同侧连接棒遮挡,椎体旋转≥9°且<13°;2级,一侧椎弓根螺钉的尖部在同侧连接棒的外侧,椎体旋转≥13°。此分级系统可用于快速评估术估顶椎去旋转程度,并评估脊柱曲轴随时间的发展。由两名独立的外科医师测量,取平均值。结果:机器人组与导航组患者的性别、年龄、BMI以及疾病种类的差异无统计学意义(P>0.05),两组患者有可比性。66例患者共置入1259枚椎弓根螺钉,其中机器人组共计置入627枚椎弓根螺钉,导航组共计置入632枚螺钉。机器人组术中第一次椎弓根螺钉置入的准确率为94.7%,其中0级、1级、2级和3级螺钉分别占88.5%、6.2%、2.4%和2.9%;导航组术中第一次椎弓根螺钉置入的准确率为89.2%,其中0级、1级、2级和3级螺钉分别占80.1%、9.2%、6.3%和4.4%。机器人组术中第一次椎弓根螺钉置入的准确率明显高于导航组(94.7%vs 89.2%),差异有统计学意义(P=0.000)。机器人组术后椎弓根螺钉的置入的准确率为96.7%,其中0级、1级、2级和3级螺钉分别占90.0%、6.7%、1.4%和1.9%;导航组术后椎弓根螺钉的置入的准确率为93.0%,其中0级、1级、2级和3级螺钉分别占82.9%、10.1%、5.4%和1.6%。机器人组术后椎弓根螺钉置入的准确率明显高于导航组(96.7%vs93.0%),差异有统计学意义(P=0.004)。机器人组术后椎弓根螺钉的误置率为3.3%,导航组为7.0%,差异有统计学意义(P=0.004)。机器人组凸侧和凹侧的误置率分别为1.9%和1.4%,导航组分别为4.8%和2.2%;机器人组内侧和外侧的误置率分别为1.4%和1.9%,导航组分别为1.3%和5.7%。机器人组和导航组均未观察到与椎弓根螺钉相关的并发症。机器人组的手术时间(6.55±0.99 hours)高于导航组(6.12±0.92 hours),但差异无统计学差异(P>0.05)。两组术中出血量(515.4±153.9vs492.4±160.3 ml)、术后住院时间(9.13±2.61 vs 10.36±3.44d)的差异无统计学意义(P>0.05)。机器人组患者的术中辐射剂量(44.22±5.34μSv)明显高于导航组(32.81±4.22μSv),差异有统计学意义(P=0.000),但机器人组和导航组医生的术中辐射剂量的差异无统计学意义(P>0.05)。机器人组和导航组患者术前及术后的Cobb角及顶椎旋转角的差异无统计学意义(P>0.05)。机器人组和导航组术后主弯Cobb角和顶椎旋转角较术前均有明显改善,差异有统计学意义(P<0.05)。机器人组和导航组术后顶锥旋转分级的差异无统计学意义(P>0.05)。结论:机器人辅助下椎弓根螺钉置入技术和导航辅助下椎弓根螺钉置入技术都可以取得良好的临床疗效。与导航辅助下椎弓根螺钉置入相比,机器人辅助下椎弓根螺钉置入技术增加了平均手术时间,但提高了椎弓根螺钉置入的准确性。在导航辅助椎弓根螺钉置入的技术中,插入导针后进行三维扫描可提高椎弓根螺钉置入的准确性。更多还原

【Abstract】 Backgrounds:Scoliosis is a common three-dimensional(3D)deformity of the spine,defined as a lateral curvature of the spine in the coronal plane,often accompanied by varying degrees of spinal rotation.Scoliosis is usually defined by a curve of≥ 10°(Cobb Angle measurement),and the disorder can affect respiratory function and body balance,and have other effects,in severe cases.Posterior scoliosis correction with pedicle screws has become the standard treatment for patients with severe spinal curvature,rapid progression of disease in adolescence,and neurologic symptoms.However,screw placement in scoliosis surgery is challenging owing to vertebral rotation and smaller pedicle size(especially at the concave side)and a more complex 3D structure than normal.These issues increase the potential risk of screw misplacement and cause complications,such as vascular,nerve,and pleural injury.Currently,the fluoroscopyassisted free-hand technique is the principal method for pedicle screw implantation.Previous studies reported that the rate of screw malpositioning caused by free-hand pedicle screw insertion during scoliosis correction range from 1.5%to 43%,with an overall average perforation rate of 20.3%.In scoliosis cases,even when the pedicles’ rajectories are predetermined and tapped correctly,screws may be inserted into the pedicles incorrectly owing to axial rotation,especially at the apical levels.To improve pedicle screw positioning,several techniques have been developed,including navigation technologies,such as computed tomography(CT)-guided or robot-assisted technologies,to decrease the risk of misplaced screws and the associated complications.In recent years,intraoperative computed tomography(CT),which includes the use of O-arm and 3D C-arm,has been used in spinal surgery for navigation assistance.Moreover,O-arm navigation provides intraoperative 3D fluoroscopic imaging with an image quality similar to that of CT,and reduces the time needed for computerassisted surgery.However,navigation techniques may still be subject to human error and surgeon tremor to some extent.Robot technology has been developing since its inception.The orthopedic robot adds a mechanical arm on the basis of navigation technology,which makes the placement of pedicle screws more convenient and accurate.The advantages of roboticguided techniques include increased accuracy,shorter surgical time,and reduction of intraoperative radiation exposure.At present,the Tianji robot independently developed in China(Beijing Tianzhihang Medical Technology Co.,Ltd.)has been successfully applied.The advantage of Tianji robot lies in the combination of robot and navigation system,and it can track the position of screw placement and the respiratory movement of patients in real time,thus reducing the misplacement rate of pedicle screws.However,at present,the research on the application of Tianji robot technique and navigation technique in scoliosis correction is limited.In addition,the comparison of the accuracy and safety of pedicle screw placement between robot technique and navigation technique also needs to be further explored.Objectives:We reported the clinical use of robot-assisted pedicle screw placement and navigationguided pedicle screw placement for scoliosis surgery and compared the clinical outcomes,accuracy,and safety between the two techniques.Methods:The imaging data and clinical score data of 66 patients with scoliosis who underwent scoliosis surgery in Qilu Hospital of Shandong University from January 2020 to December 2022 were analyzed retrospectively.Thirty-two patients were treated with robot-assisted pedicle screw implantation(robot group),including 6 males and 26 females,with an average of 14.9±3.1 years,including 23 cases of idiopathic scoliosis,7 cases of congenital scoliosis,and 2 cases of neuromuscular scoliosis.Thirty-four patients were treated with pedicle screw implantation assisted by navigation technique(navigation group),including 7 males and 27 females,with an average of 15.3±2.9 years,including 27 cases of idiopathic scoliosis,5 cases of congenital scoliosis,and 2 cases of neuromuscular scoliosis.In the present study,3D images were used to evaluate the accuracy of the first pedicle screw placement during operation.The accuracy of placement of all pedicle screws postoperatively was evaluated using reconstructed CT image data to improve accuracy.Perforation was assessed using the following screw misplacement grading systems.Each screw position was classified as grade 0(no perforation,with the screw completely within the pedicle),grade 1(perforation ≤2 mm),grade 2(perforation>2 to ≤4 mm),or grade 3(perforation>4 mm or>1 screw diameter).Grade 0 and 1 screw positions were considered clinically acceptable,while grades 2 and 3 indicated perforation.In accordance with this grading system,the screw misplacement rates were determined.Operation time,radiation exposure,blood loss,postoperative hospital stay,and postoperative complications related to the surgeries were investigated and compared between the groups.Full-length radiographs were obtained using a standard protocol to measure the preoperative and postoperative Cobb angle.The apical vertebral rotation(AVR)in robot group and freehand group was measured on CT images preand postoperatively.The AVR grade was measured on a standard posteroanterior radiograph postoperatively.When both pedicle screw tips were visible central to the two rods(classified as Grade 0 vertebrae),CT measurements of vertebral rotation were between 0° and 8°.In Grade 1 vertebrae,one pedicle screw tip was hidden behind the ipsilateral rod,and CT measurements of vertebral rotation were between 9° and 12°.In Grade 2 vertebrae,one pedicle screw tip was lateral to its ipsilateral rod,and CT measurements of vertebral rotation were greater than 13°.This grading system could be used to quickly assess postoperative residual AVR and possibly to evaluate for the development of crankshaft over time.Results:There was no significant difference in sex,age,BMI and type of disease between the robot group and the navigation group,so there was comparability between the two groups.A total of 1259 pedicle screws were implanted in 66 patients,including 627 in the robot group and 632 in the navigation group.The accuracy of the first pedicle screw placement in the robot group was 94.7%,of which grade 0,grade 1,grade 2 and grade 3 screws accounted for 88.5%,6.2%,2.4%and 2.9%,respectively.The accuracy of the first pedicle screw placement in the navigation group was 89.2%,of which grade 0,grade 1,grade 2 and grade 3 screws accounted for 80.1%,9.2%,6.3%and 4.4%,respectively.The accuracy rate of the first pedicle screw placement during operation was significantly higher in robot group(94.7%)than in navigation group(89.2%;P=0.000).In the robot group,the accuracy of pedicle screw placement after operation was 96.7%,of which grade 0,grade 1,grade 2 and grade 3 screws accounted for 90.0%,6.7%,1.4%and 1.9%,respectively.The accuracy of postoperative pedicle screw placement in the navigation group was 93.0%,of which grade 0,grade 1,grade 2 and grade 3 screws accounted for 82.9%,10.1%,5.4%and 1.6%,respectively.The accuracy rate of pedicle screws placement postoperatively was significantly higher in robot group than in navigation group(96.7%vs 93.0%,P=0.004).The misplacement rate of pedicle screws was 3.3%in the robot group and 7.0%in the navigation group,and the difference was statistically significant(P=0.004).The misplacement rates of convex side and concave side in robot group were 1.9%and 1.4%,and those of navigation group were 4.8%and 2.2%,respectively.The misplacement rates of medial and lateral of robot group were 1.4%and 1.9%,and those of navigation group were 1.3%and 5.7%,respectively.There were no complications related to pedicle screw placement in robot group and navigation group.The operation time in the robot group(6.55±0.99 hours)was higher than that in the freehand group(6.12±0.92 hours),but there was no significant difference.There was no significant difference in intraoperative blood loss and postoperative hospital stay between the two groups(P>0.05).The patient’s intraoperative radiation dose of the robot group(44.22±5.34 μSv)was significantly higher than that of the navigation group(32.81±4.22 μSv,P=0.000),but there was no significant difference in surgeon’s intraoperative radiation dose between the two groups(P>0.05).There was no significant difference in preoperative and postoperative Cobb angles and AVR between robot group and navigation group(P>0.05).The Cobb angles of the main curve in robot group and navigation group improved significantly postoperatively(P<0.05).There were no significant differences in the AVR grade postoperatively between robot group and navigation group(p>0.05).Conclusions:Robot-assisted pedicle screw placement and navigation-guided pedicle screw placement can achieve good clinical results.Compared with the navigation-guided pedicle screw placement,robot-assisted pedicle screw placement can effectively improve the accuracy in scoliosis surgery.A three-dimensional scan after insertion of the K-wire may increase the accuracy of pedicle screw placement in the navigation technique.更多还原