Application of Spinal Robotic Navigation Technology to Minimally Invasive Percutaneous Treatment of Spinal Fractures: A Clinical, Non-Randomized, Controlled Study

Abstract

Objective: To introduce a new robotic navigation system that assists pedicle screw implantation and verify the accuracy and stability of the system. Methods: Pedicle screw placements were performed on the thoracic vertebrae (T)9–Lumbar vertebrae (L)5 thoracolumbar vertebrae of cadavers using robotic guidance. The operative duration, puncture success, correction, and correction time were assessed. Additionally, a total of 30 thoracolumbar fractures from September 2017 until June 2019 were included in a clinical study. Two groups were evaluated: the robotic guidance group and freehand group. Both sexes were evaluated. Mean ages were 47.0 and 49.1 years, respectively, in the robotic and freehand groups. Inclusion criteria was age >18 years and a thoracolumbar fracture. Intervention was the operative treatment of thoracolumbar fractures. Outcome parameters were the operation time, intraoperative bleeding, and fluoroscopic data. The accuracy of the pedicle screw placement and screw penetration rate of the two groups were compared using intraoperative fluoroscopic axial images. Results: The success rate for 108 one-time nail placements in cadavers was 88% and two-time nail placement was 100%. Vertebral punctures at L5 took the longest to perform and achieve correction. Clinically, there were no significant differences in patients' sex, body mass index, age distribution, or intraoperative bleeding between the groups. The average X-ray exposure time for patients and operators were 37.69 ± 9.24 s and 0 s in the robotic group (significantly lower than in the freehand group: 81.24 ± 6.97 s vs 56.29 ± 7.93 s, respectively). Success rates for one-time screw placements were 98.64 and 88.46% in the robotic and freehand groups, respectively, which is significant. Screw penetration rates (1.36% vs 11.54%, robotic vs freehand), were significantly different. Conclusions: The robotic system improved the accuracy and safety of pedicle screw internal fixation and reduced patients' and operators' intraoperative radiation exposure.