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

NCT ID: NCT03075384

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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 Description

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.

Conditions

Zygomatic Fractures

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

open reduction and internal fixation

A classic method was used to treat unilateral complicated zygomatic fractures without the assistance of computer-assisted navigation system

computer-assisted navigation system

Intervention Type: PROCEDURE

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

Interventions

computer-assisted navigation system

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China College of Stomatology

OTHER

Sponsor Role: collaborator

Xiao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Xiao Zhang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lei Liu, DMD

Role: STUDY_DIRECTOR

Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

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Other Identifiers

Xiao_owen

Identifier Type: -

Identifier Source: org_study_id