Clinical Trial: Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Peking University

Current Primary Outcome: Zygomatic Symmetry [ Time Frame: 1 month ]

Measurement the zygomatic symmetry of postoperative CT scan


Original Primary Outcome: Measurement of postoperative CT scan of patient [ Time Frame: 1 month ]

Current Secondary Outcome:

  • 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.
  • Facial Symmetry [ Time Frame: 3 month ]
    Facial symmetry on the Visual Analog Scale and three-dimensional camera


Original Secondary Outcome:

  • 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.
  • Subjective Evaluation [ Time Frame: 3 month ]
    Method:Visual Analogue Scale/Score


Information By: Peking University

Dates:
Date Received: November 29, 2011
Date Started: December 2011
Date Completion:
Last Updated: October 20, 2015
Last Verified: October 2015