Clinical Trial: Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Application of Computer-Assisted Navigation System in the Treatment of Unilateral Complicated Zygomatic Complex Fractures: A Randomized Controlled Trial

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Xiao Zhang

Current Primary Outcome: accuracy of the reduction of the fractures [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: West China College of Stomatology

Dates:
Date Received: March 4, 2017
Date Started: March 2014
Date Completion:
Last Updated: March 8, 2017
Last Verified: March 2017