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OpenTrials
Completed

NCT Number: NCT01487018

Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

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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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Beijing, 100081, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigation Surgery

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.

Other names: Computer-Aided Surgery, Surgical Navigation

Traditional Surgery

Procedure

To compare with the experamental group.

Other names: Control Group

Primary outcomes

  1. Zygomatic Symmetry

    Time frame: 1 month

    Measurement the zygomatic symmetry of postoperative CT scan

Secondary outcomes

  1. 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.

  2. Facial Symmetry

    Time frame: 3 month

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

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 7, 2011
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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