Evaluation of the Accuracy of Zygomatic Complex Fracture Reduction and Orbital Volume Restoration Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial

Abstract

This study is intended to investigate the effect of a totally digital workflow versus the standard protocol on the reduction of the zygomatic complex fracture. A precise reduction is mandatory to minimize functional and cosmetic issues. Conventional reduction approaches rely mostly on intraoperative clinical judgment, and fixation using a stock plate may result in varying surgical accuracy. Twenty-eight patients with unilateral zygomatic fractures who followed the inclusion criteria were allocated and divided equally into 2 groups: the study group, a virtual bone reduction was carried out in the operating theater using a surgical stent and a customized fixation plate, while the control group was managed according to standard protocol. The outcome was the accuracy of reduction based on the restoration of orbital volume. Which is measured using computed tomography, the study group demonstrated a statistically significant accuracy compared with the control group. The mean difference between groups was −1854.61, with a 95% CI from −3474.22 to −235.01. This difference was statistically significant (P=0.028). While the digital workflow was associated with a higher cost, the mean cost difference between groups was 1235.71, with a 95% CI from 89.21 to 2382.22. This difference was statistically significant (P=0.036). Clinically, the study group showed a higher function and aesthetic restoration. These results support the use of a fully digital workflow as a reliable and predictable strategy with no risk of postoperative complications or need for redo surgery.