- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487018
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
Status
Completed
Conditions
Intervention / Treatment
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
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Peking, China, 100081
- Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
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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:
- post-traumatic unilateral deformities of the zygomaticomaxillary complex
- The interval after the primary injury should be more than 21 days
- Meet the operation indication
- Voluntarily join this study with informed consents
Exclusion Criteria:
- Obviously asymmetric of craniofacial structure
- Poor compliance of patient
- 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.
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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:
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Active Comparator: Traditional Surgery
To compare with the experimental arm.
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To compare with the experamental group.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zygomatic Symmetry
Time Frame: 1 month
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Measurement the zygomatic symmetry of postoperative CT scan
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy evaluation of CT image
Time Frame: 1 month
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Anatomic contour of pre-operation design affected side was superimposed on postoperative one.
Discrepancy between preoperative simulation and postoperative result was calculated.
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1 month
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Facial Symmetry
Time Frame: 3 month
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Facial symmetry on the Visual Analog Scale and three-dimensional camera
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3 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- gongx31480528
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.
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