Objectives: To test the hypothesis that intraoperative cone beam computed tomography (CBCT) using the Allura augmented reality surgical navigation (ARSN) system in a dedicated hybrid operating room (OR) matches computed tomography (CT) for identification of pedicle screw breach during spine surgery.
Methods: Twenty patients treated with spinal fixation surgery (260 screws) underwent intraoperative CBCT as well as conventional postoperative CT scans (median 12 months after surgery) to identify and grade the degree of pedicle screw breach on both scan types, according to the Gertzbein grading scale. Blinded assessments were performed by three independent spine surgeons and the CT served as the standard of reference. Screws graded as Gertzbein 0 or 1 were considered clinically accurate while grades 2 or 3 were considered inaccurate. Sensitivity, specificity, and negative predictive value were the primary metrics of diagnostic performance.
Results: For this patient group, the negative predictive value of an intraoperative CBCT to rule out pedicle screw breach was 99.6% (CI 97.75-99.99%). Among 10 screws graded as inaccurate on CT, 9 were graded as such on the CBCT, giving a sensitivity of 90.0% (CI 55.5-99.75%). Among the 250 screws graded as accurate on CT, 244 were graded as such on the CBCT, giving a specificity of 97.6% (CI 94.85-99.11%).
Conclusions: CBCT, performed intraoperatively with the Allura ARSN system, is comparable and non-inferior to a conventional postoperative CT scan for ruling out misplaced pedicle screws in spinal deformity cases, eliminating the need for a postoperative CT.
Key points: • Intraoperative cone beam computed tomography (CT) using the Allura ARSN is comparable with conventional CT for ruling out pedicle screw breaches after spinal fixation surgery. • Intraoperative cone beam computed tomography can be used to assess need for revisions of pedicle screws making routine postoperative CT scans unnecessary. • Using cone beam computed tomography, the specificity was 97.6% and the sensitivity was 90% for detecting pedicle screw breaches and the negative predictive value for ruling out a pedicle screw breach was 99.6%.
Keywords: Cone beam computed tomography; Image-guided surgery; Pedicle screws; Sensitivity and specificity.