机器人辅助置入胸腰椎椎弓根螺钉的临床研究

  目的  探讨天玑骨科手术机器人系统辅助下置入胸腰椎椎弓根螺钉的临床效果。  方法  将2018年8月—2020年5月于安庆市第一人民医院脊柱外科接受胸腰椎椎弓根螺钉内固定手术的40例患者,根据手术方式分为机器人辅助手术组和“C”形臂透视下徒手组,2组各20例。记录每台手术椎弓根螺钉的置入时间及术中透视次数,根据术后X线和三维CT评价2组螺钉的位置情况(准确率),评判螺钉置入的准确性和安全性。  结果  机器人辅助手术组每枚螺钉置入时间为平均(13.85±1.41)min,“C”形臂X线透视下徒手置钉组每枚螺钉置入时间为平均(14.03±1.84)min,2组数据差异无统计学意义(P>0.05)。机器人辅助手术组共置入螺钉94枚,Ⅰ级螺钉90枚,Ⅱ级螺钉4枚,Ⅲ级螺钉0枚,准确率为95.74%(90/94);“C”形臂X线透视下徒手置钉组共置入螺钉96枚,Ⅰ级螺钉83枚,Ⅱ级螺钉10枚,Ⅲ级螺钉3枚,准确率为86.46%(83/96);2组数据对比,差异有统计学意义(P＜0.05)。机器人辅助手术组术中的透视次数为(8.15±1.53)次,“C”形臂X线透视下徒手置钉组术中的透视次数为(13.35±2.58)次,2组比较差异有统计学意义(P＜0.01)。  结论  天玑骨科手术机器人辅助手术能明显提高置入椎弓根螺钉的准确性及安全性,同时也减少了术中放射线辐射,但并未明显增加置钉时间,在脊柱手术中有着巨大的手术潜能和优势。      

导航模板辅助置入枢椎椎弓根螺钉的临床应用

目的:评价导航模板辅助置入枢椎椎弓根螺钉的准确性和安全性。方法:2013年7月-2015年7月对13例需要行枢椎椎弓根螺钉置入手术的患者,术前根据三维重建图像,利用计算机辅助设计及三维打印技术设计制作枢椎及其椎弓根螺钉置入导航模板,术中应用导航模板辅助置入枢椎弓根螺钉26枚,术后CT扫描评价螺钉位置,记录有无与螺钉置入相关的并发症。结果:术中共应用13个个体化导向模板,辅助植入枢椎椎弓根螺钉26枚。术后X线观察及CT断层扫描显示所有螺钉进钉点准确,进钉方向适当。枢椎椎弓根螺钉准确性分级:0级24枚,Ⅰ级2枚。结论:导航模板辅助置入枢椎椎弓根螺钉,准确率高,安全可行。     

骨科导航技术在胸腰椎手术中的应用研究

目的 探讨骨科导航系统在胸腰椎手术中的应用价值. 方法 收集我科2011-08～2012-04收治的20例应用骨科手术导航系统的胸腰椎手术患者(导航组),共植入椎弓根螺钉86枚;2011-01 ～2011-07对照15例采用传统的方法进行椎弓根螺钉植入术(徒手组),共植入64枚螺钉.术后通过复查X线片或者螺旋CT,将两组患者椎弓根螺钉的位置进行对比分析. 结果 导航组植入的86枚螺钉中80枚位置优良,优良率为93.0％,相应徒手组植入64枚螺钉中52枚位置优良,优良率为81.3％,导航组椎弓根螺钉位置的优良率明显优于徒手组,差异具有统计学意义(P＜0.05),并且导航组没有出现并发症. 结论 应用骨科手术导航系统可提高螺钉置入位置的准确性,降低手术并发症.     

计算机导航在腰椎椎弓根内固定术中的应用

目的:应用计算机数字化技术三维重建辅助腰椎椎弓根内固定手术,提高一次性置钉成功率和准确性。方法:56例腰椎椎弓根钉内固定病例,分为数字技术手术组(A组)和传统技术手术组(B组)。其中A组26例,行螺旋CT扫描后导入Mimics软件进行三维重建,开展术前计划及个体化测量以指导手术,置钉81枚;B组30例,采用传统徒手技术置钉86枚。所有病例术中记录钉置入的一次性成功率,术后再次进行螺旋CT扫描评估置钉准确性。结果:A、B两组的一次性置入成功率分别为88.9%和61.6%;椎弓根螺钉置入准确率分别为98.8%和81.4%。两组置钉一次性置入成功率和准确率差异有统计学意义P<0.05。结论:螺旋CT结合计算机数字化技术三维重建辅助手术技术,可以显著提高椎弓根螺钉置入的一次性成功率和准确性。     

计算机导航辅助下经关节突寰枢关节螺钉治疗齿状突骨折的临床研究

目的 通过比较计算机导航辅助下寰枢关节螺钉置钉方法(导航组)与传统C臂透视指导下寰枢关节螺钉置钉方法（传统组）的临床疗效,评估计算机导航辅助技术在经关节突寰枢关节螺钉治疗齿状突骨折中的临床应用价值。方法 对28例经关节突寰枢关节螺钉后路寰枢融合治疗齿状突骨折患者进行回顾性分析,其中导航组13例,传统组15例,比较两组患者手术时间、透视时间、出血量及术后并发症等情况,术后影像学检查评估两组患者螺钉植入的准确性。结果 28例患者共放置寰枢关节螺钉55枚。平均手术时间导航组154.9min,传统组182.2min,两组差异有统计学意义（P＜0.01),平均透视时间导航组（41.3s）显著少于传统组(64.3s)（P＜0.01)。术后影像学检查显示导航组螺钉位置均满意,传统组中6枚螺钉位置不满意。结论 计算机导航辅助下置入寰枢关节螺钉可以提高手术的安全性和准确性,减少患者和术者射线暴露,缩短手术时间,是治疗齿状突骨折的有效方法。     

国内首次机器人辅助椎弓根螺钉置入脊柱侧凸矫形手术(附14例报告)

目的 总结机器人辅助椎弓根螺钉植入脊柱侧凸矫形手术的体会并验证其置钉的准确性。 方法 选择14例脊柱侧凸患者,男性6例,女性8例,特发性脊柱侧凸12例,先天性脊柱侧凸2例。行后路机器人辅助椎弓根螺钉内固定矫形手术,术中记录机器人置钉时间、透视次数和注册时间等,术后CT 验证螺钉位置。 结果 共使用机器人植入螺钉148枚,平均配准次数(移动平台)1.7次,平均透视次数为11.2次,平均配准时间(平台安装+透视配准)时间为16.4min。从配准完成后,平均每枚螺钉置钉时间为2.4min。冠状面Cobb角由术前50.1°(20°-63°)矫正至12.8°(2°-28°),平均矫形率74%。术后CT平扫显示,机器人辅助置钉的准确率为95.3%。 结论 Mazor机器人辅助脊柱手术定位精度高、手术安全性好,将成为未来脊柱外科发展的趋势。     

3D打印个体化定位导板与计算机导航系统治疗颈椎骨折脱位的疗效比较

目的比较3D打印个体化定位导板与计算机导航系统治疗颈椎骨折脱位的临床效果。方法 2012年2月至2013年12月,23例颈椎骨折脱位行后路椎弓根螺钉内固定术患者被纳入研究,随机分为3D打印个体化椎弓根定位导航模板辅助置钉组(导板组)12例,二维红外线引导计算机辅助导航系统置钉组(导航组)11例。两组患者性别、年龄、致伤原因、损伤节段、神经功能分级等一般资料比较,差异均无统计学意义(P>0.05),具有可比性。记录两组患者手术时间、出血量,通过术后CT记录矢状面螺钉置入角(SSA)、椎弓根皮质与螺钉的关系(PSR)及置钉成功率。结果两组手术时间和出血量比较差异有统计学意义(P<0.05);导板组和导航组SSA分别为(3.7±0.9)°和(3.5±1.7)°,差异无统计学意义(P>0.05)。导板组和导航组置钉成功率分别为93.8%(45/48);和93.1%(41/44),差异无统计学意义(P>0.05)。结论应用3D打印个体化定位导板和计算机导航系统辅助颈椎弓根螺钉的置入均有较高置入准确率。个体化定位导板手术时间及术中出血量更少,临床应用证实该方法完全可行,应该具有较好的应用前景。     

腰椎滑脱导航下椎弓根螺钉植入的手术时间比较

目的:探讨腰椎滑脱患者于计算机辅助ct影像导航下植入椎弓根螺钉对手术时间的影响?方法:58例腰5骶1滑脱需行后路椎弓根螺钉固定及椎间融合术的患者,随机分为两组,分别采用计算机导航辅助下植钉及采用解剖定位+c臂机辅助下植钉,比较两组的植钉准确率和手术时间?射线暴露时间的差异?结果:术后经ct扫描比较两组椎弓根钉位置,导航植钉组准确率显著高于传统植钉组(p = 0.038 < 0.05),自2006年10月至2008年5月,统计两组手术植钉时间,导航植钉组手术时间(79.04 ± 13.74)min少于传统方法植钉组(85.93 ± 12.86)min,但无统计学意义p = 0.053?但自2007年4月后,两组手术时间分别为(72.95 ± 10.70)min和(87.14 ± 11.23)min,有统计学差异p = 0.000?计算机辅助导航植钉组的射线暴露时间较传统植钉组平均减少6.6 s,p = 0.000?结论:随着操作熟练度的提高,采用ct影像导航下植入腰椎滑脱患者的椎弓根螺钉能提高植钉准确率,同时不增加手术时间,减少了患者创伤?     

COA: 不同方法颈椎椎弓根螺钉置入精确性的临床对比研究

研究背景：因为颈椎解剖结构复杂和椎弓根细小,颈椎椎弓根螺钉置入精确性较差,螺钉置入失误造成神经血管损伤的风险大,临床应用受到限制。北京积水潭医院自2001年10月开始透视辅助颈椎椎弓根螺钉内固定临床应用,自2002年12月开始CT导航辅助颈椎椎弓根螺钉内固定,2005年11月开始术中即时三维电动C型臂导航辅助颈椎椎弓根螺钉内固定。本研究对82例患者进行了前瞻性的队列研究,以评估不同方法颈椎椎弓根螺钉置入的精确性。 目的：对透视、CT导航和术中即时三维电动C型臂导航三种方法辅助颈椎椎弓根螺钉置入的精确性进行对比分析。 方法;对82例颈椎椎弓根螺钉内固定患者进行了前瞻性的队列对照研究。术后CT扫描判断螺钉置入的精确性。优：螺钉完全位于椎弓根内;可：螺钉穿出椎弓根皮质不超过螺钉直径的25%;差：螺钉穿出椎弓根皮质超过25%。 结果：透视组24例患者共置入145枚螺钉,其中优96枚(66.2%)、可37枚(25.5%)、差12枚(8.3%);CT导航组29例患者共置入159枚螺钉, 其中优141枚(88.7%)、可14枚(8.8%)、差4枚(2.5%);术中即时三维电动C型臂导航组29例患者共置入140枚螺钉, 其中优127枚(90.7%)、可13(9.3%)。三组病例均未出现严重神经血管损伤并发症。 结论：透视辅助颈椎椎弓根螺钉置入的精确性在三种技术中最差。CT导航和术中即时三维电动C型臂导航可以提高颈椎椎弓根螺钉置入的精确性。术中即时三维电动C型臂导航由于其操作简便,临床精度高,易于为操作者掌握,具有更好的临床应用前景。     

计算机导航系统在脊柱内固定术中的应用及护理配合

目的探讨计算机导航系统在脊柱内固定术中应用时手术室护士的护理配合。方法应用计算机导航辅助进行脊柱内固定术共93例,植入椎弓根螺钉462枚,对手术前后的患者进行护理,观察置钉准确率、手术时间、术中出血量等。结果术后经X射线摄片证实,置钉准确451枚,准确率达97.7%;手术室护士术中与手术者配合默契,手术医生满意率提高。结论计算机辅助导航技术是提高手术成功率的有效手段和重要保障。     

基于C形臂X 光机透视的手术导航系统在椎弓根螺钉植入的应用

目的研究基于C形臂X光机透视的手术导航系统在椎弓根螺钉植入过程中的应用。方法分别使用基于C形臂X光机透视的手术导航技术及传统C形臂X光机透视定位技术,在4具脊柱尸体标本上植入48枚椎弓根螺钉。并进行CT扫描了解椎弓根位置。测量所有螺钉与椎弓根皮质的距离。按照螺钉偏差情况将螺钉位置分为4级。完全位于椎弓根内为A级,破出椎弓根皮质但不超过2mm为B级,破出椎弓根皮质2-4mm为C级,破出椎弓根皮质4mm为D级。结果使用基于C形臂X光机透视的手术导航技术植入的48枚螺钉中,总共有2例螺钉出现偏差。其中1例B级,1例C级。46枚(95.8%)位于椎弓根内,2枚(4.2%)出现偏差,使用传统C形臂X光机透视定位方法植入48枚螺钉,其中有9例破出椎弓根皮质。5例B级,3例C级,1例D级。39枚(81.2%)位于椎弓根内,9枚(18.8%)出现偏差。结论本套导航系统利用普通的C形臂X光机,可以引导椎弓根螺钉准确植入,偏差率很低,并可大大减少X射线辐射。     

计算机导航辅助下椎弓根螺钉内固定疗效观察

目的探讨计算机导航技术应用于临床椎弓根螺钉固定术的疗效。方法2007年2月至2008年12月对36例胸腰椎骨折、腰椎滑脱伴脊柱不稳的患者,年龄21～72岁,平均51.3岁,分别采用计算机导航系统(A组16例)和传统X线透视法(B组20例)行椎弓根钉固定术。比较两组置钉位置和术中使用X线次数。结果手术均顺利完成,未发生血管和神经损伤并发症,两组螺钉位置分级比较差异有统计学意义(P<0.05)。两组患者透视次数比较差异有统计学意义(P<0.05)。结论计算机导航辅助椎弓根螺钉固定是一项安全的手术,且手术精度高。     

Comparison of the clinical accuracy of cervical (C2–C7) pedicle screw insertion assisted by fluoroscopy, computed tomography- based navigation, and intraoperative three-dimensional C-arm navigation

Background The complicated anatomy of the cervical spine and the variation among pedicles reduces the accuracy and increases the risk of neurovascular complications associated with screw implantation in this region. In this study, we compared the accuracy of cervical （C2-C7） pedicle screw fixation assisted by X-ray fluoroscopy, computed tomography （CT）-based navigation, or intraoperative three-dimensional （3D） C-arm navigation.Methods This prospective cohort study was performed in 82 consecutive patients who underwent cervical pedicle screw fixation. The accuracy of screw insertion was assessed by postoperative CT scan with 3D reconstruction. The accuracy of screw insertion was assessed as： excellent （screw completely within pedicle）; acceptable （≤ 1 mm screw outside pedicle cortex）; poor （〉1 mm screw outside pedicle cortex）.Results A total of 145 screws were inserted in 24 patients who underwent C-arm fluoroscopy. Of these, 96 screws （66.2%） were excellent, 37 （25.5%） were acceptable, and 12 （8.3%） were poor. One hundred and fifty-nine screws were inserted in 29 patients in the CT-based navigation group. Among these, 141 （88.7%） were excellent, 14 （8.8%） were acceptable, and 4 （2.5%） were poor. A total of 140 screws were inserted in 29 patients in the intraoperative 3D C-arm navigation group, of which 127 （90.7%） were excellent, and 13 （9.3%） were acceptable. No severe or permanent neurovascular complications associated with screw insertion were observed in any patient.Conclusione CT-based and intraoperative 3D C-arm navigation were similarly accurate, and were both significantly more accurate than C-arm fluoroscopy for guiding cervical pedicle screw fixation. They were able to accurately guide the angle and depth of screw placement using visual 3D images. These two techniques are therefore preferable for high-risk cervical pedicle screw fixation. The ease and convenience of intraoperative 3D C-arm navigation suggests that it may replace virtual-fluoroscopy and CT-based navigation systems in future clinical applications.     

Computer-assisted navigation systems for insertion of cannulated screws in femoral neck fractures: a comparison of bi-planar robot navigation with optoelectronic navigation in a Synbone hip model

Background  Computer-assisted procedures have recently been introduced for navigated femoral neck screw placement. Currently there is little information available regarding accuracy and efficiency of the different navigated procedures. The aim of this study was to compare two fluoroscopic navigation tracking technologies, a novel bi-planar robot navigation and standardized optoelectronic navigation, versus standard freehand fluoroscopic insertion in a Synbone hip model.

Methods  Eighteen fixed Synbone hip models were divided into 3 groups. C-arm navigated cannulated screws (AO-ASIF, diameter 7.3 mm) were inserted using freehand targeting (control group). A novel bi-planar robot system (TINAV, GD2000) and an optoelectronic system (Stryker OTS Navigation System) were used for the navigated procedures (robot group and optoelectronic group). Accuracy was measured using radiographic evaluation including the measurement of screw parallelism and decentralization, and joint penetration. To evaluate the efficiency, the number of guidewire passes, operative time and fluoroscopic images taken were noted.

Results  The two computer-assisted systems provided significantly improved accuracy compared to the freehand technique. Each of the parameters, including guidewire passes and number of fluoroscopy images, was significantly lower when using the computer-assisted systems than for freehand-unguided insertion (P <0.05), but operative time was significantly shorter when using freehand-unguided insertion than for the computer-assisted systems (P <0.05). Accuracy, operative time and number of fluoroscopy images taken were similar among the two navigated groups (P >0.05), but guidewire passes in the robot group were significantly less than in the optoelectronic group (P <0.05).

Conclusions  Both bi-planar robot navigation and optoelectronic navigation were similarly accurate and have the potential to improve accuracy and reduce radiation for freehand fluoroscopic targeting for insertion of cannulated screws in femoral neck fractures. Guidewire passes in the robot group were significantly less than in the optoelectronic group. However, both navigated procedures were associated with time-consuming registration and high rates of failed matching procedures.

     

CT三维重建配合3D打印技术在辅助寰枢椎椎弓根螺钉置入的应用价值评估

目的:探讨CT三维重建配合3D打印技术在辅助寰枢椎椎弓根螺钉置入的应用价值。方法:通过CT三维重建的多种后处理技术明确寰枢椎病变13例作为观察组,再将CT三维重建、逆向工程原理及快速成形技术相结合,设计出一种新型的导航模板,辅助椎弓根螺钉置入,并与13例之前已通过X线透视置钉法的病例（对照组）进行置钉效果比较。结果:对照组13例共置椎弓根螺钉41枚,其中Ⅰ类置钉9枚,Ⅱ类置钉18枚,Ⅲ类置钉14枚,成功率65.9%;观察组共打印颈椎模型13例,设计导向模板21个,5例由于先前通过X线透视仅在枢椎两侧的椎弓根内置钉,只制作出枢椎的导航模板;模拟手术同样置钉41枚,其中Ⅰ类置钉15枚,Ⅱ类置钉21枚,Ⅲ类置钉5枚,成功率87.8%。结论:CT三维重建的各种后处理技术不仅能够准确的判断寰枢椎病变,并能配合3D打印技术,制作出个体化的导航模板,使上颈椎椎弓根螺钉的置入变得既安全又省时,并能在术后准确评估置钉效果。     

个体化导航模板辅助儿童胸椎椎弓根螺钉置钉准确性实验研究

目的:利用计算机辅助设计与快速成形技术为儿童胸椎椎弓根螺钉置入提供一种个性化、精确定位的方法。方法:对4具胸椎尸体标本进行CT扫描,根据CT扫描资料,利用逆向工程原理及快速成型技术设计制造出个体化导航模板,利用个体化导航模板在尸体标本上辅助置入胸椎椎弓根螺钉,所有螺钉的置入由同一位具有腰椎椎弓根螺钉置钉经验但无胸椎椎弓根螺钉置钉经验的骨科医师进行操作,随后根据CT扫描评价椎弓根螺钉位置。结果:共设计制作48个导航模板,辅助置入96枚胸椎椎弓根螺钉,CT扫描发现所有螺钉均准确置入相应椎弓根内。结论:数字化导航模板辅助胸椎椎弓根螺钉置钉准确性高,操作简单,为儿童胸椎椎弓根螺钉的准确置入提供了一种新的、可行方法。     

CT三维导航系统辅助胸椎椎弓根钉治疗胸椎骨折

目的 探讨CT三维导航技术在胸椎椎弓根钉植入手术中的应用方法和植钉准确性.方法 采用CT三维导航技术对24例胸椎骨折患者行椎弓根钉(102枚)植入手术进行立体引导,术后行CT内固定层面扫描,观察椎弓根螺钉植入的准确性.同时总结C臂机透视引导下22例胸椎骨折椎弓根钉(98)的植钉准确性,并与CT三维导航引导组进行对比分析.结果 术后CT扫描显示CT三维导航组102枚胸椎椎弓根钉I级99枚(97.1%),Ⅱ级(突破椎弓根皮质≤2 mm)3枚,Ⅲ级(突破椎弓根皮质>2 mm)0枚.Ⅱ级有1枚螺钉位置偏于椎弓根内侧,其余均偏在椎弓根外侧.c臂机透视组98枚胸椎椎弓根钉I级88枚(89.8%),Ⅱ级8枚,Ⅲ级2枚.Ⅱ级和Ⅲ级所有螺钉位置偏于椎弓根外侧,Ⅲ级中一例患者出现顽固性胸背痛.余两组临床无神经损伤症状.两组I级差异有统计学意义(P<0.05).结论 计算机辅助导航技术利用CT三维重建影像进行术中导航给术者提供即时的,多维的清晰图像,准确地按照计算机设计的精确进钉路线进行手术内固定.提高了胸椎椎弓根钉植入的安全性和精确性.     

Minimally invasive transforaminal lumbar interbody fusion aided with computer-assisted spinal navigation system combined with electromyography monitoring

Background  Minimally invasive techniques are gaining wide-spread application in lumbar fusion surgery, because they may have advantage over conventional open surgery in approach-related morbidity. This research was aimed to evaluate the safety and accuracy of the techniques of minimally invasive transforaminal lumbar interbody fusion by using a computer-assisted spinal navigation system combined with electromyography monitoring.

Methods  Sixteen patients underwent minimally invasive transforaminal lumbar interbody fusion. A computer-assisted spinal navigation system and electromyography were used for guiding pedicle screw placement. The operative duration, blood loss, complications, and fluoroscopic time were recorded. Clinical outcome was assessed by Visual Analog Scale and Oswestry Disability Index. Radiographic images were obtained to evaluate the accuracy of pedicle screw placement and fusion rates.

Results  The Visual Analog Scale and Oswestry Disability Index scores were vastly improved postoperatively. A total of 64 pedicle screws were implanted and three were regarded as misplacement by post-operative CT scan. Three screw trajectories were adjusted according to intra-operative stimulus-evoked electromyography monitoring. The average fluoroscopy time in each patient was 31.8 seconds, which equals to 7.9 seconds per pedicle screw. No patients had instrument related neurological complications, infection, implant failure or revision. Successful fusion was found in all patients.

Conclusions  The combination of navigation system and real-time electromyography monitoring can make the minimally invasive operation more safe and accurate while decreasing radiation exposure time of the medical staff and patient and minimizing the chance and the degree of the pedicle screw misplacement.