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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075384
• Other study ID #: Xiao_owen
• Status: Completed
• Phase: N/A
• First received: March 4, 2017
• Last updated: March 8, 2017
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: West China College of Stomatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Zygomatic Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xiao Zhang	West China College of Stomatology

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of the reduction of the fractures		one year