智能化骨折微创复位手术机器人系统治疗不稳定型骨盆骨折的随机对照研究  

A clinical randomized controlled trail of an intelligent robot-assisted minimally invasive reduction system for treatment of unstable pelvic fractures

作　　者：肖鸿鹄 赵春鹏[1] 曹奇勇[1] 张立佳 葛宇峰 朱罡 王豫[3,4] 吴新宝 Xiao Honghu;Zhao Chunpeng;Cao Qiyong;Zhang Lijia;Ge Yufeng;Zhu Gang;Wang Yu;Wu Xinbao(Department of Orthopaedic Trauma,Beijing Jishuitan Hospital,Beijing 100035,China;Rossum Robot Co.,Ltd,Beijing 100083,China;School of Biological Science and Medical Engineering,Beihang University,Beijing 100083,China;Beijing Advanced Innovation Center for Biomedical Engineering,Beijing 100083,China)

机构地区：[1]北京积水潭医院创伤骨科,北京100035 [2]北京罗森博特科技有限公司,北京100083 [3]北京航空航天大学生物与医学工程学院,北京100083 [4]北京市生物医学工程高精尖创新中心,北京100083

出　　处：《中华创伤骨科杂志》2023年第4期341-350,共10页Chinese Journal of Orthopaedic Trauma

基　　金：北京市科技计划项目(Z201100005420033);国家自然科学基金(NSFC61871019);北京市自然科学基金(19L2011)。

摘　　要：目的:在机器人辅助或透视下经皮螺钉内固定治疗不稳定型骨盆骨折中,比较机器人辅助微创复位和透视辅助下徒手闭合复位的近期疗效。方法:采用前瞻性随机对照研究方法,纳入2021年12月至2022年10月期间北京积水潭医院创伤骨科收治的35例新鲜不稳定型骨盆骨折患者。按照随机数字表法将患者分为两组:观察组17例,男10例,女7例;年龄(44.0±17.4)岁;采用机器人辅助微创复位、机器人辅助或透视下经皮螺钉内固定技术治疗。对照组18例,男12例,女6例;年龄(38.8±15.0)岁;采用透视辅助下徒手闭合复位,机器人辅助或透视下经皮螺钉内固定技术治疗。比较两组患者的术中出血量、手术时间、复位成功率、复位误差、Matta复位优良率、透视次数和时间、Matta功能评分等。结果:两组患者术前一般资料比较差异均无统计学意义(P>0.05),具有可比性。观察组术中透视次数[(32.4±17.5)次]、透视时间[(19.8±10.4)s]均显著少于对照组[(60.8±26.6)次、(38.2±16.1)s],观察组复位成功率100.0%(17/17),显著高于对照组的72.2%(13/18),差异均有统计学意义(P<0.05)。两组患者在术中出血量、手术时间、复位误差、Matta复位优良率、12周Majeed功能评分比较,差异均无统计学意义(P>0.05)。结论:智能化骨盆骨折微创复位机器人可以完成自主复位路径规划,并在三维影像的实时监控下完成骨盆骨折的微创复位。与传统的方式相比,复位成功率高、放射线暴露少,对新鲜的不稳定型骨盆骨折的微创治疗具有明显优势。Objective To compare the short-term efficacy between our self-designed intelligent robot-assisted minimally invasive reduction system and conventional freehand reduction assisted by fluoroscopy in the treatment of unstable pelvic fractures by robot or fluoroscopy-assisted internal fixation with percutaneous screws.Methods A prospective randomized controlled trial was conducted to include eligible 35 patients with unstable pelvic fracture who were admitted to Department of Orthopaedic Trauma,Beijing Jishuitan Hospital from December 2021 to October 2022.They were randomized into 2 groups.The observation group[17 cases,10 males and 7 females with an age of(44.0±17.4)years]was treated with robot-assisted minimally invasive reduction,followed by robot-assisted or fluoroscopic internal fixation with percutaneous screws;the control group[18 cases,12 males and 6 females with an age of(38.8±15.0)years]was treated with freehand reduction assisted by fluoroscopy,followed by robot-assisted or fluoroscopic internal fixation with percutaneous screws.The 2 groups were compared in terms of operation time,intraoperative bleeding,successful reduction,reduction quality,incidence of surgical complications and postoperative functional scores.Results The 2 groups were comparable because there were no significant differences in the preoperative general data between them(P>0.05).The intraoperative fluoroscopy frequency[(32.4±17.5)times]and fluoroscopy time[(19.8±10.4)s]in the observation group were significantly lower or shorter than those in the control group[(60.8±26.6)times and(38.2±16.1)s],and the rate of successful reduction in the observation group was 100.0%(17/17),significantly higher than that in the control group[72.2%(13/18)](P<0.05).There was no significant difference between the 2 groups in intraoperative bleeding,operation time,reduction error,excellent and good rate of reduction after operation by Matta scoring,or Majeed functional score at 12 weeks after operation(P>0.05).Conclusion In the treatment of unstable pel

关 键 词：机器人 外科手术 微创性 骨盆 骨折 骨折复位 

分 类 号：R687.3[医药卫生—骨科学]