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Clinical Trial 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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01487018
Study type Interventional
Source Peking University
Contact
Status Completed
Phase Phase 3
Start date December 2011
Completion date July 2015

See also
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Not yet recruiting NCT04836130 - Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique N/A
Completed NCT04719312 - Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture N/A
Not yet recruiting NCT03484676 - Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture N/A
Completed NCT03075384 - Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System N/A
Recruiting NCT05438784 - Application of CAD-CAM Technology in Orbital Bone Reconstruction N/A
Completed NCT05381337 - A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture N/A
Completed NCT05695872 - A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures N/A