SpineNav-01手术导航系统辅助脊柱椎弓根螺钉置入的临床研究

 目的  比较计算机手术导航系统SpineNav-01辅助手术与传统X线透视辅助手术在辅助胸、腰骶椎椎弓根螺钉置入手术中的准确性和安全性,评价该手术导航系统在临床应用中的效果。 方法 纳入33例接受椎弓根螺钉内固定手术的患者,收集临床及影像学资料。按辅助手术方式的不同分成两组:传统组,螺钉置入在X线透视辅助下完成;导航组,螺钉置入在基于术前三维CT数据的手术导航系统辅助下完成。术后三维CT评价两组螺钉的位置情况,比较两组螺钉置入的准确性和安全性,记录每枚螺钉置入时间、置钉相关并发症,导航组另记录注册时间。结果 两组间年龄、性别以及螺钉节段分布情况差异无统计学意义。传统组共置入108枚螺钉,其中胸椎22枚,腰、骶椎86枚,准确率为73.1% (79/108),安全率为96.3% (104/108),出现神经相关并发症2例,1例接受翻修手术;导航组共置入108枚螺钉,其中胸椎30枚,腰、骶椎78枚,准确率为87.0% (94/108),安全率为100% (108/108),出现神经相关并发症1例。两组间螺钉置入准确率及安全率比较,差异有统计学意义 (P<0.05),导航组螺钉置入准确性及安全性优于传统组。传统组每枚螺钉置入时间为2～5 min,平均3.2 min;导航组每枚螺钉置入时间为1～4 min,平均2.2 min;导航组共注册25次,每次注册时间3～9 min,平均4.8 min。 结论 基于术前三维CT数据的SpineNav-01手术导航系统能显著提高胸、腰椎椎弓根螺钉置钉的准确性和安全性。

Clinical study of pedicle screw placement utilizing SpineNav-01 computer-assisted navigation system

Objective   To compare the safety and accuracy of computer-assisted surgical navigation system (SpineNav 01,China) and fluoroscopy guidance in pedicle screw insertion of thoracic vertebra and lumbosacral vertebra,giving the system a preliminary evaluation within clinical application.Methods   Thirty-three consecutive patients with a diagnosis of thoracic and lumbosacral disease who underwent a surgical approach of thoracic and lumbosacral pedicle screw fixation using two methods were evaluated.The population was divided into two groups:in traditional surgery group (fluoroscopy guidance),traditional X-ray guidance was used to assist pedicle screw positioning;whereas in navigated surgery group (navigation assitance),pedicle screw insertion was assisted by intraoperative three-dimensional imaging navigation based on preoperatively computed tomography data acquisition.Epidemiological data of patients and pedicle screw distribution in two groups were analyzed and compared.The evaluation and classification of the screw positioning was performed on the basis of a postoperative CT scan according to certain classifications.The time per pedicle screw insertion and its complication in two group was recorded,while the time per registration recorded in navigated surgery group.Results   There was no statistical difference found between the groups concerning age,sex,pedicle screw distribution.In traditional surgery group,out of the 108 cases of screw inserted,79 cases were accrate (73.1%) and 104 cases were in safe zone.In navigated surgery group,out of the 108 cases of screw inserted,94 cases were accrate (87.0%).The rate of accuracy was higher in navigated surgery group with a statistical significance,so was the rate of safty.Two cases with neurologic complaint appeared in traditional surgery group,one of which accepted revision surgery.One case in navigated surgery group complained about paresthesia that subsided during follow-up without any treatment.The mean time per pedicle screw insertion for traditional surgery group was 3 minutes on average,and for navigated surgery group it was 2.2 minutes.The mean time per registration in navigated surgery group was 4 minutes.Conclusions   That SpinNav-01 system based on three-dimensional CT data has an elevated accuracy and safty compared to traditional fluoroscopy guidance in pedicle screw positioning.