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NCT Number: NCT03075384

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral ZMC fractures including complete monofragment zygomatic or tetrapod fracture, multifragment or comminuted fracture
  • Patients were sane and the age were between 18 to 60 years
  • Patients suffered facial deformity and dysfunction which need be treated by operation
  • There is no contraindication in patients
  • The study were conducted after patient's informed consent

Exclusion criteria

  • Cases in which technical problems or registration fails occur and patients who were lost to follow-up within 1 year are excluded from this study.

Treatment and study plan

computer-assisted navigation system

Procedure

The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures

Primary outcomes

  1. accuracy of the reduction of the fractures

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Xiao Zhang

Other

Collaborators

  • West China College of Stomatology

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2017
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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