Objective: To evaluate the efficacy and safety of spinal navigation with intra-operative 3D-imaging modality in lumbar pedicle screw fixation.
Methods: 401 patients with lumbar degenerative disorders or fracture were randomly divided into 2 groups: Group A, undergoing pedicle screw fixation by spinal navigation with intra-operative 3D-imaging system, and Group B undergoing pedicle screw fixation by traditional method. The position of pedicle screw was assessed by intra-operative 3D-imaging system. The excellent rate of pedicle screw position, mean time of pedicle screw implantation, operating time, blood loss, and post-operative complication were compared.
Results: The excellent rate of pedicle screw position was higher Group A was 95.3%, significantly higher than that of Group B (84.1%, P < 0.001). The mean time of pedicle screw implantation and operating time of Group A were (3.70 +/- 0. 65) min, significantly shorter than that of Group B [(7.83 +/- 2.32) min, P < 0.001]. The blood loss amount of Group A was (272 +/- 153) ml, significantly less than that of Group B [(455 +/- 289) ml, P < 0.05]. However, the total operating time of Group A was (134 +/- 48) min, not significantly different from that of Group B [(179 +/- 62) min, P > 0.05].
Conclusion: With spinal navigation combined with the intra-operative 3D-imaging modality, implantation of lumbar pedicle screw is more simplified, more accurate, safer, and with shorter operating time.