Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-07-31

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.

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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.

Conditions

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Zygomatic Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Navigation Surgery

Intervention Type PROCEDURE

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 Surgery

To compare with the experimental arm.

Group Type ACTIVE_COMPARATOR

Traditional Surgery

Intervention Type PROCEDURE

To compare with the experamental group.

Interventions

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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.

Intervention Type PROCEDURE

Traditional Surgery

To compare with the experamental group.

Intervention Type PROCEDURE

Other Intervention Names

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Computer-Aided Surgery Surgical Navigation Control Group

Eligibility Criteria

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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