骨科手术导航系统辅助置钉的实验效果综合性评价

Comprehensive evaluation of the experimental effect of nail placement assisted by the orthopedic surgical navigation system

目的应用AKSO-Ⅱ骨科手术导航定位系统,进行脊柱(腰椎、胸椎、颈椎)后路经皮穿刺椎弓根螺钉置入,以及股骨颈骨折空心钉内固定手术,测试该导航定位准确度及置入手术的可行性,验证其有效性及安全性。方法选取3只巴马猪为研究对象,对照组使用传统手术方式、实验组采用AKSO-Ⅱ骨科手术导航定位系统(安徽埃克索医疗机器人有限公司),分别在颈椎/胸椎/腰椎椎弓根和股骨颈四个部位,经皮或开放手术中置入克氏针,参照Gertzbein-Robbins分类标准及Hamelinck的方法评定两组手术的成功率及优良率;通过对比规划路径与真实路径空间角度、钉道入点和规划入点、钉道止点和规划止点的偏差,进行导航一致性评价;通过对比针调整次数及克氏针置入时间和X射线暴露时间、剂量、次数,辅助评估手术有效性;然后在新鲜冰冻尸体上进行尝试性验证。结果在相同实验条件下,采用AKSO-Ⅱ骨科手术导航定位系统引导与传统手术方式相比,手术成功率:实验组为95%,高于对照组(72.2%),有统计学差异(P<0.05)。手术优良率:实验组高于对照组(98.2%vs 78.1%),具有显著统计学差异(P<0.05)。针调整次数:股骨、颈椎、胸椎、腰椎手术实验中,实验组均少于对照组具有统计学差异(P<0.05)。克氏针置入时间:第一组中,实验组与对照组无差异,经过学习后,第二、三组实验组明显短于对照组,具有统计学差异(P<0.05)。手术出血量:实验组明显少于对照组,具有统计学差异(P<0.05)。X射线暴露时间:实验组明显短于对照组,具有统计学差异(P<0.05)。X射线剂量:实验组明显少于对照组,具有统计学差异(P<0.05)。结论采用AKSO-Ⅱ骨科手术导航定位系统简单、精准、安全、微创,可以大幅度减小辐射剂量和手术时长,对患者和术者均带来益处。

s:Objective To apply AKSO-Ⅱ orthopaedic surgical navigation and positioning system for posterior percutaneous puncture pedicle screw placement in the spine(lumbar,thoracic and cervical vertebrae),as well as for internal fixation of hollow nails in femoral neck fracture model,to test the application of the accuracy of this navigation and positioning and the feasibility of the placement surgery,and to validate the effectiveness and safety of this navigation and positioning system.Methods Three Parma pigs were selected as research subjects,the control group used traditional surgical methods,the experimental group used the AKSO-Ⅱ orthopaedic surgical navigation and positioning system(Anhui Exo Medical Robotics Co.,Ltd.),and four parts of the cervical spine/thoracic spine/lumbar spine pedicles and the femoral neck were performed,respectively,with markers implanted in the percutaneous or open surgeries,and the markers implanted in the surgery by referring to the Gertzbein-Robbins classification standard and the Hamelinck s method to assess the success and excellence rates of the two groups;navigation consistency evaluation by comparing the deviation of the spatial angle of the planned path and the real path,the nail path entry point and the planned entry point,and the nail path stop point and the planned stop point;assessment of the effectiveness of the surgery by comparing the number of pin adjustments and the time of Gertzbein's pin placement and the time,dose,and number of X-ray exposures to assist in evaluating the effectiveness of the surgery;and then on fresh frozen cadavers for Trial validation.Results Femoral,cervical,thoracic,and lumbar spine surgeries were successfully completed under the same experimental conditions using AKSO-Ⅱ orthopaedic surgical navigation and positioning system guidance versus traditional surgical methods.According to the surgical evaluation results surgical success rate:the test group was 100%,higher than the control group,but no statistical difference was seen.Surgical excellence rate:the experimental group was higher than the control group,with a statistically significant difference(P<0.05).Number of needle adjustments:in the femoral,cervical,thoracic,and lumbar spine surgery trials,the test group was less than the control group,with a statistically significant difference in the thoracic spine surgery(P<0.05).Kirschner needle placement time:there was no difference between the experimental group and the control group,and after study,the experimental group was significantly shorter than the control group,with statistical difference(P<0.05).X-ray exposure time:the experimental group was significantly shorter than the control group,with statistical difference(P<0.05).X-ray dose:the experimental group was significantly less than the control group,with statistical difference(P<0.05).Conclusion The use of AKSO-Ⅱ orthopaedic surgical navigation and positioning system is simple,precise,safe and minimally invasive,which can greatly reduce the radiation dose and operation time,and bring benefits to both patients and operators.