Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

October 20, 2015 updated by: Gong Xi, Peking University

Evaluation of the Application of Point-to-Point Computer-Assisted Navigation for Mirroring-Reconstructing of Unilateral Posttraumatic Zygomatic Deformity: A Randomized Controlled Trial

Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

Study Overview

Detailed Description

Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Peking, China, 100081
        • Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. post-traumatic unilateral deformities of the zygomaticomaxillary complex
  2. The interval after the primary injury should be more than 21 days
  3. Meet the operation indication
  4. Voluntarily join this study with informed consents

Exclusion Criteria:

  1. Obviously asymmetric of craniofacial structure
  2. Poor compliance of patient
  3. Any other condition that do not fit to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigation Surgery
To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Other Names:
  • Computer-Aided Surgery
  • Surgical Navigation
Active Comparator: Traditional Surgery
To compare with the experimental arm.
To compare with the experamental group.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zygomatic Symmetry
Time Frame: 1 month
Measurement the zygomatic symmetry of postoperative CT scan
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy evaluation of CT image
Time Frame: 1 month
Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated.
1 month
Facial Symmetry
Time Frame: 3 month
Facial symmetry on the Visual Analog Scale and three-dimensional camera
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yi Zhang, Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Zygomatic Fractures

Clinical Trials on Navigation Surgery

3
Subscribe