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

NCT03075384 | Completed DMC

• 1 other identifier: Xiao_owen
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Zygomatic Fractures

Keywords

computer-assisted navigation system

Outcome Measures

Primary Outcomes (1)

• accuracy of the reduction of the fractures

  one year

Study Arms (1)

open reduction and internal fixation

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

Procedure: computer-assisted navigation system

Interventions

computer-assisted navigation system PROCEDURE

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

open reduction and internal fixation

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

patients with unilateral complicated zygomatic-complex fractures

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiao Zhang: lead
• West China College of Stomatology: collaborator

Related Publications (25)

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• Wang TH, Ma H, Tseng CS, Chou YH, Cai KL. Using Free Navigation Reference Points and Prefabricated Bone Plates for Zygoma Fracture Model Surgeries. J Med Biol Eng. 2016;36:316-324. doi: 10.1007/s40846-016-0144-x. Epub 2016 Jun 6.

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  PMID: 23714993 BACKGROUND

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MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Lei Liu, DMD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2017
• First Posted: March 9, 2017
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 9, 2017

Record last verified: 2017-03