机器人辅助置入与徒手置入椎弓根螺钉的对比研究

A comparative study of robot assisted insertion and traditional free-hand pedicle screw technique

目的评价机器人辅助椎弓根螺钉置入的安全性及准确性,并与徒手置钉进行比较研究。方法本研究通过前瞻性对照的方法,将2015年12月至2016年3月期间20例需行椎弓根螺钉内固定术的脊柱疾病患者纳入机器人辅助组,其中男11例,女9例;年龄11~85岁,平均54.1岁。同期选取20例脊柱疾病患者纳入徒手置钉组,其中男6例,女14例;年龄18~75岁,平均54.8岁。术前对所有患者进行脊柱CT薄层扫描,机器人辅助组利用机器人辅助系统进行术前置钉规划,术中辅助置钉,记录透视次数及置钉时间等,术后复查CT根据判断螺钉位置。对数据进行统计学比较分析。结果本研究共置入椎弓根螺钉394枚,机器人辅助组1例重度僵硬性脊柱侧凸患者因自身原因改用徒手置钉,其他19例成功应用机器人引导置入124枚螺钉。机器人辅助组(平台安装+透视匹配)平均透视次数为(7.0±2.5)次,徒手置钉组平均透视次数为(12.6±4.5)次,差异有统计学意义(P=0.003)。平均机器匹配时间(机器匹配+平台安装)为(18.9±7.2)min,机器人辅助组平均每枚螺钉置入时间(3.7±1.5)min,徒手置钉组平均每枚螺钉置入时间(4.3±0.8)min,差异无统计学意义(P=0.261)。术中透视和术后CT显示所有机器人引导置入的螺钉(100%)均准确的置入椎弓根内。根据Rampersaud分类法,机器人辅助组124枚螺钉位置均为A类。徒手置钉组Rampersaud分类为A类198枚,B类28枚,C类16枚,D类4枚。其准确率(A类和B类)为91.8%,差异有统计学意义(P=0.032)。机器人组平均总手术时间(268.3±74.0)min,徒手置钉组平均总手术时间(267.5±65.3)min,差异无统计学意义(P=0.980)。机器人组平均手术出血量(285.0±240.2)ml,徒手置钉组平均手术出血量(640.0±389.3)ml,差异具有统计学意义(P=0.031)。结论机器人辅助置入椎弓根可提高置钉准确率,减少术中透视次数,降低辐射量,进而提高手术安全性。其在脊柱微创、翻修、脊柱畸形手术中具有良好的应用前景。

Objective To evaluate the clinical application of Renaissance robotic-assisted system for spinal pedicle screw insertion, to compare the placement accuracy safety of robotic-assisted insertion with traditional freehand technique. Methods This was a perspective controlled trial. Twenty consecutive patients（ 11 males, 9 females） with spinal disorders, who underwent pedicle screws insertion between December 2015 and March 2016, were enrolled in the robotic-assisted group. The mean age was 54.1 years（ range： 11-85 years）. Twenty consecutive patients（ 6 males, 14 females） were enrolled in the traditional free-hand group. The mean age was 54.8 years（ range： 18-75 years）. Whole spinal 1.0 mm CT scan was used for all patients. Renaissance robotic-assisted system was used in the robotic-assisted group for preoperative planning. Intraoperative fluoroscopy was applied to match the information with the robotic-assisted system during the procedure. Times of intraoperative fluoroscopy and time of each pedicle screw placement were recorded. Postoperative whole spinal CT scan was applied to check the position of pedicle screws. Data were statistically compared. Results A total of 394 pedicle screws were successfully implanted. Actually 124 pedicle screws were implanted with robotic-assist（ robotic-assist was aborted and 24 screws were manually placed）. Average times for intraoperative fluoroscopy per procedure were（ 7.0 ± 2.5） in the robotic-assisted group（ platform mounting and registration）, and average（ 12.6 ± 4.5） times for intraoperative fluoroscopy per procedure in hand-free group（ P〈0.05）. Average（ 18.9 ± 7.2） min for mounting the platform and registration. Average（ 3.7 ± 1.5） min to insert each screw in the robotic-assisted group, and average（ 4.3 ± 0.8） min to insert each screw in the handfree group（ P〈0.05）. Intraoperative fluoroscopy and postoperative CT scan showed all screws were placed into the pedicle accurately with robotic-assist. According to Dr. Rampersaud classification, 124 screws were graded as A in the robotic-assisted group. Total 198 screws were graded as A, 28 were graded as B, 16 were graded as C, 4 were graded as D in traditional hand-free group. The accuracy rate was 91.8%（ including grade A and B） with statistical significance（ P = 0.032）. Average operation time of the robotic-assisted group was（ 268.3 ± 74.0） min, while free-hand group（ 267.5 ± 65.3） min with no statistical significance（ P = 0.980）. Average blood loss of robotic-assisted group was（ 285.0 ± 240.2） ml, while（ 640.0 ± 389.3） ml in the free-hand group with statistical significance（ P = 0.031）. Conclusions Robotic-assisted system improves the accuracy of implant and the safety of spinal surgery. The times and radiation dosage of intraoperative fluoroscopy are reduced. It is of a great prospect to be applied not only in spinal percutaneous surgery, but also revision and deformity.