Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Zygomatic Fractures

Intervention / Treatment
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* Procedure: Navigation Surgery
* Procedure: Traditional Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation Surgery<br>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. | Procedure: Navigation Surgery<br>* 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.<br>* Other names: Surgical Navigation;|
| Active Comparator: Traditional Surgery<br>To compare with the experimental arm. | Procedure: Traditional Surgery<br>* To compare with the experamental group.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy evaluation of CT image | 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 | Facial symmetry on the Visual Analog Scale and three-dimensional camera | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry