Zygomatic Fractures Clinical Trial
Official title:
Application of Computer-Assisted Navigation System in the Treatment of Unilateral Complicated Zygomatic Complex Fractures: A Randomized Controlled Trial
Many studies show that computer-assisted navigation system have been available to treat zygomatic-complex fractures. However, most of them are case reports or clinical experiences lacking multiple variables and controlled design. The aim of this study was to evaluate the accuracy of the computer-assisted navigation system by a randomized controlled trial with multiple variables.
In this prospective randomized controlled trial, twenty patients with unilateral complicated
zygomatic fractures were divided into experimental and control groups. Patients in the
experimental group were treated with open reduction and internal fixation with the
assistance of surgical navigation technology, and patients in the control group without it.
Preoperative and postoperative CT data were obtained to measure surgical landmarks
discrepancy between the 2 groups. The Chi-square Test and t-test were conducted to test
whether there was significant difference in the accuracy between the two groups. Evaluating
the effect of fixation by the data and clinical symptoms.
Twenty patients with unilateral complicated zygomatic-complex fractures received operation.
All patients healed and their function and facial contour were improved obviously.
Postoperative clinical symptoms were not significantly different between the two groups
(P>0.05). Compared with the control group, discrepancy of surgical landmarks measured by
software Geomagic studio 11, Brainlabiplan CMF 3.0 were significantly low in the
experimental group (P<0.05). Software measurement showed the symmetry of zygomatic area and
the effect of the fixation in the experimental group were more satisfactory than the control
group.
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