骨科机器人辅助下行经皮内固定术治疗胸腰椎骨折的置钉准确度及学习曲线分析

The accuracy and learning curve analysis of the robot assisted percutaneous thoracolumbar screw placement

中文关键词:  骨科机器人  胸腰椎骨折  椎弓根螺钉置入  学习曲线

英文关键词:Orthopedic robot  Thoracolumbar fracture  Pedicle screw insertion  Learning curve

中文摘要:

  【摘要】 目的：探讨运用“天玑”骨科机器人辅助完成经皮胸腰椎骨折内固定术的置钉准确度以及学习曲线。方法：回顾性分析2019年3月~2020年1月由我院应用“天玑”骨科手术机器人辅助下行经皮胸腰椎内固定术治疗单节段新鲜胸腰椎骨折的患者资料24例，其中男性14例，女性10例，年龄22~54岁，平均39.3±9.7岁。所有患者中T12骨折9例，L1骨折10例，L2骨折4例，L3骨折1例。根据手术日期的先后将患者分成A、B、C、D四个组，每组6例。所有患者术后3~5d完善手术节段CT，根据Gertzbein-Robbins分类标准，对置钉情况进行评估，同时计算置钉准确度（A类螺钉占比）。统计各组患者的路径规划时间（示踪器放置完毕至机器臂开始移动）、螺钉置入时间（机器臂开始移动至透视置入螺钉位置满意）、总手术时间（切开至切口消毒包扎完毕）资料，应用曲线回归分析方法，评价机器人辅助经皮胸腰椎骨折内固定技术的学习曲线。结果：各组患者骨折类型、总手术节段数、手术节段、置入螺钉数量、年龄及性别差异无统计学意义（P＞0.05），数据具有可比性。本研究中A类螺钉100枚，B类螺钉2枚，无C、D类螺钉，置钉准确度为98.03%。各组置钉准确度A组96.0%、B组96.1%、C组100%、D组100%，各组间差异无统计学意义（P＞0.05）。1、2号病例置入导针轨迹与规划轨迹存在偏差，经2次规划调整后成功置入螺钉。路径规划时间：A组44.83±13.60min、B组31.67±1.86min、C组29.17±2.14min、D组29.33±1.37min；A组与C、D组有统计学差异（P＜0.01），B组与A组、C组、D组无统计学差异（P＞0.05），C组与D组无统计学差异（P＞0.05）。总手术时间A组137.83±18.00min、B组120.33±5.85min、C组120.50±4.59min、D组119.67±5.24min，A组与C、D组有显著差异（P＜0.05），B组与A组、C组、D组无统计学差异（P＞0.05），C组与D组无统计学差异（P＞0.05）；螺钉置入时间A组46.17±6.68min、B组40.67±2.25min、C组40.00±2.90min、D组38.67±3.01min，A组与C、D组有显著差异（P＜0.05），B组与A组、C组、D组无统计学差异（P＞0.05），C组与D组无统计学差异（P＞0.05）。曲线回归分析显示，随着病例数的增加路径规划时间、螺钉置入时间、总手术时间明显降低（P＜0.001），在中期12例之后达到相对稳定。结论：“天玑”骨科手术机器人辅助下行经皮胸腰椎置钉准确度高。该技术应用早期学习曲线陡峭，随着手术例数的增加学习曲线很快趋于平稳。

英文摘要:

  【Abstract】 Objectives: To explore the accuracy and learning curve of percutaneous screw placement assisted by "Tianji" orthopedic robot during internal fixation of thoracolumbar fracture. Methods: A retrospective anal?鄄ysis was performed in 24 patients with single-segment thoracolumbar fracture who were consecutively enrolled in the hospital from March 2019 to January 2020. They were treated by the same surgeon using "Tianji" or?鄄thopedic surgical robot. There were 14 males and 10 females with the age of 22-54 years(averaged 39.29±9.73 years). Of all patients, 9 cases were of T12 fracture, 10 cases of L1, 4 cases of L2, and 1 case of L3. Based on the operation date, patients were divided into group A, group B, group C, and group D. CT scan was performed 3-5 days after operation. The accuracy of screw placement was estimated using the proportion of Category A screws according to Gertzbein-Robbins classification. Path-planning duration (Duration from placing spinous process Clamp towards completing before movement of positioner), screw implantation time(from the beginning of robot arm moving to screw implanted into a satisfied position under fluoroscopy), and total operation time (from incision to wound disinfection and bandaging) were statistically analyzed. The learning curve of robot assisted percutaneous thoracolumbar fracture internal fixation technology was evaluated by curvi?鄄linear regression analysis. Results: There were no statistically significant differences in fracture types, total number of surgical segments, screws numbers, age, and gender among the 4 groups(P>0.05). The total accura?鄄cy of screw placement in this study was 98.03%(100/102), including 100 screws of Category A, 2 screws of Category B, and no screw of Category C and D. The difference of screw setting accuracy among the four groups is not statistically significant(P>0.05, grade A 96.0%, grade B 96.1%, grade C 100%, and grade D 100%). In two cases, number 1 and number 2, there was deviation between the guide pin trajectory and the planned trajectory. After two planning adjustments, the screws were successfully implanted. Of path-planning duration(group A 44.83±13.60min, group C 29.17±2.14min, and group D 29.33±1.37min), there were signifi?鄄cant differences between group A and group C/ group D(P<0.01), and there was no statistical difference be?鄄tween group C and group D(P>0.05). Of the total operation time(group A 137.83±18.00min, group C 120.50±4.59min, and group D 119.67±5.24min) and the screw-implantation time(group A 46.17±6.68min, group C 40.00±2.90min, and group D 38.67±3.01min), group A has significant differences from group C/ group D(P<0.05), and group C has no statistical difference from group D(P>0.05). The path-planning duration, total surgery duration and screw-implantation durationof group B(31.67±1.86, 120.33±5.85, and 40.67±2.25 respec?鄄tively) were not statistically different from those in groups A, C, and D(P>0.05). After the curvilinear regres?鄄sion analysis, it showed that the path-planning time(P<0.001), the screw-implantation time(P<0.001), and the total surgery time(P<0.001) significantly decreased with the increasing numbers of patients. And after the num?鄄ber reaching 12 in the medium stage, the three parameters stayed relatively stable. Conclusions: "Tianji" Orthopedic Robot has higher accuracy and stability in percutaneous thoracolumbar internal screw fixation. And this technology has certain learning curve in its early application. The learning curve quickly becomes stable with the increase in cases.