Spine Surgery with Electronic Conductivity Device: A Prospectively Multicenter Randomized Clinical Trial and Literature Review

Abstract

Objective Improving accuracy and safety of pedicle screw placement is of great clinical importance. Electronic conductivity device (ECD) can be a promising technique with features of affordability, portability, and real‐time detection capabilities. This study aimed to validate the safety and effectiveness of a modified ECD. Methods The ECD underwent a modification where six lamps of various colors, and it was utilized in a prospectively multicenter randomized controlled clinical trial involving 96 patients across three hospitals from June 2018 to December 2018. The trial incorporated a self‐control randomization with an equal distribution of left or right side of vertebral pedicle among two groups: the free‐hand group and the ECD group. A total of 496 pedicle screws were inserted, with 248 inserted in each group. The primary outcomes focused on the accuracy of pedicle screw placement and the frequency of intraoperative X‐rays. Meanwhile, the secondary indicator measured the time required for pedicle screw placement. Results were presented as means ± SD. Paired samples t‐test and χ2‐test were used for comparison. Furthermore, an updated review was conducted, which included studies published from 2006 onwards. Results Baseline patient characteristics were recorded. The primary accuracy outcome revealed a 96.77% accuracy rate in the ECD group, compared to a 95.16% accuracy rate in the free‐hand group, with no significant differences noted. In contrast, ECD demonstrated a significant reduction in radiation exposure frequency when compared to the free‐hand group (1.11 ± 0.32 vs. 1.30 ± 0.53; p < 0.001), resulting in a 14.6% reduction. Moreover, ECD displayed a decrease of 30.38% in insertion time (70.88 ± 30.51 vs. 101.82 ± 54.00 s; p < 0.001). According to the results of the 21 studies, ECD has been utilized in various areas of the spine such as the atlas, thoracic and lumbar spine, as well as sacral 2‐alar‐iliac. The accuracy of ECD ranged from 85% to 100%. Conclusion The prospectively randomized trial and the review indicate that the use of ECD presents a secure and precise approach to the placement of pedicle screws, with the added benefit of reducing both procedure time and radiation exposure.

Keywords

• Accuracy
• Electronic conductivity device
• Navigation surgery
• Pedicle screw
• Radiation exposure