Systematic Review of Surgical Success, Complications, Revision Rates, Radiation Dosage, and Operative Time of 3D-Navigated vs. Non-Navigated Spinal Procedures.

Abstract

Objectives: 3D navigation offers real-time guidance in surgery. However, there is limited and inconsistent data regarding the usability, safety, and efficacy. To address gaps in knowledge about 3D navigation in spinal surgery, we conducted a comprehensive review of success rates, complications, revisions, radiation exposure, and operative time associated with FDA-approved 3D surgical navigation tools.

Methods: This study adhered to PRISMA guidelines and used a protocol registered on PROSPERO (CRD42023404554). Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched using relevant keywords for 3D surgical navigation and spinal procedures from 1946 to March 02, 2023. Two independent reviewers assessed the studies using inclusion/exclusion criteria and risk of bias tools. Statistical analyses included one-way ANOVA, weighted-mean difference, and unpaired t-tests with Welch's correction for associations and comparisons between groups, respectively.

Results: Of the total 11,324 studies identified and 7,198 screened, 62 studies totaling 3,170 adult patients were included in this comprehensive review. Complication and surgical success rates have remained constant since 2004, with overall rates of 5.5% and 94.0%, respectively. When segmented by spinal region, complication rates may be moderately positively correlated with frequency of cervical and thoracic procedures (r = 0.25, p = 0.68). The most commonly reported complication was pedicle screw malposition or breach. A subset of 20 studies, totaling 1,554 patients, compared the performance of 3D navigation to 2D fluoroscopy or freehand navigation. There was a significant difference of 6.53% between surgical success rates of the 3D-navigated and control groups (p = 0.03). However, there was no significant difference in radiation exposure or operative time.

Conclusions: 3D navigation in spinal procedures has higher surgical success rates than 2D fluoroscopy and freehand navigation. Included studies exhibited varying limitations, including no patient follow-up (n = 1), less than 10 patients (n = 6), various types of spinal disorders (n = 1), and varying comorbidities among participants (n = 2). Improving 3D navigation tools remains imperative to decrease operative time and radiation exposure.