Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01487018
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity
Sponsor:
Peking University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: