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

ObjectiveImproving 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.MethodsThe 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.ResultsBaseline 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