Navigated pedicle screw insertion with the Surgivisio system: Malposition rate and risk factors - about 648 screws.

Purpose: Pedicle screw malposition rates vary greatly in scientific literature depending on the chosen criteria. Different techniques have been developed to lower the risk of screw malposition. Our primary objective is to evaluate the malposition rate associated with the use of the Surgivisio navigation system and to identify risk factors for screw malposition. The secondary objectives are to assess operating time and radiation data.

Materials And Methods: We performed a monocentric retrospective consecutive case series. All patients operated for pedicle screw implantation using the Surgivisio system between September 2017 and June 2020 were included. Screw positioning was evaluated on postoperative CT scans using Heary and Gertzbein classifications. Thirteen potential risk factors for screw malposition were hypothesized and tested with a univariate and multivariate analysis.

Results: Six hundred and forty-eight screws could be evaluated in 97 patients. Our study reported a 92.4% satisfactory screw implantation rate with a mean operative time per screw of 14.5±6.7minutes and a patient effective dose of 0.47±0.31 mSv per screw. One screw was neurotoxic and required an early revision (0.15%). Three risk factors for screw malposition have been identified in a multivariate analysis: female gender (OR=2.13 [1.11; 4], p=0.0219), an implantation level above D10 (OR=2.17 [1.13; 4.16], p=0.0197), and an "open" surgery (as opposed to percutaneous) (OR=3.47 [1.83; 6.56], p=0.0002).

Conclusion: Pedicle screw malposition rate and operative time with the Surgivisio navigation system are comparable with those reported in scientific literature. We theorized that intraoperative patient reference displacement could be a major cause of navigation failure.

Level Of Evidence: IV.