Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Peking University103 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Interventions

Navigation SurgeryPROCEDURE

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.

Traditional SurgeryPROCEDURE

To compare with the experamental group.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Beijing, China

Outcomes

Primary Outcomes

Zygomatic Symmetry

Measurement the zygomatic symmetry of postoperative CT scan

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 month

Facial Symmetry

Facial symmetry on the Visual Analog Scale and three-dimensional camera

Time frame: 3 month

Data from ClinicalTrials.gov

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