Clinical Study Of Pedicle Screw Placement Utilizing SpineNav-01 Computer-assisted Navigation System

Objective. To retrospectively compare the safety and accuracy of pedicle screw insertion using surgical navigation system (SpineNav-01, China) based on preoperative computed tomography (CT) data and fluoroscopy guidance in a series of patients giving the system a preliminary evaluation within clinical applicationMethods. 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 group I(fluoroscopy guidance),traditional X-ray guidance was used to assist pedicle screw positioning;whereas in group â…¡(navigation system),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 computed tomography scan according to certain classifications. The time per pedicle screw insertion in two group was recorded,with the time per registration recorded in group â…¡.Result. There was no statistical difference found between the groups concerning age, sex, pedicle screw distribution. In group I, out of the 108 screw inserted,79 was accrate(73.1%) and 104 was in safe zone; In group â…¡, out of the 108 screw inserted,94 was accrate(87.0%).The rate of accuracy was higher for group â…¡ with a statistical significance, so was the rate of safty. Two cases with neurologic complaint appeared in group â… , one of which accepted revision surgery. One case in group â…¡ complained about paresthesia that subsided during follow-up without any treatment. The mean time per pedicle screw insertion for the group I was 3 minutes on average,and the group â…¡2.2minutes. The mean time per registration in group â…¡ was 4 minutes.Conclusion. The results of this study suggest that SpinNav-01 system assist surgeons an elevated accuracy and safty compared to traditional fluoroscopy guidance in pedicle screw positioning.