Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
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|ClinicalTrials.gov Identifier: NCT03057405|
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : February 15, 2019
Background Correction of post traumatic and post-ablative orbita defects remains a challenge for the maxillofacial surgeon. The purpose of such intervention is the restoration of both function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention to the orbitavolume. Unfortunately, the results of such interventions today are still somewhat unpredictable.
The aim of this study is to determine whether 3D virtual planning combined with intra-operative navigation can increase the predictability of the outcome in function and aesthetics.
Study design Retrospective study. Demographic data, diagnostic and surgical parameters will be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in Brainlab software, and compared to the non-defected orbit.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction in Post-traumatic and Post-ablative Defects. Evaluation of the Potential of a Fully Integrated Brainlab Iplan System.|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||January 10, 2019|
|3D virtual planning + intra-operative navigation|
|3D virtual planning + intraoperative navigation + IO CBCT|
- accuracy of orbital volume reconstruction, as measured in Brainlab [ Time Frame: immediate postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057405
|Principal Investigator:||Johan Abeloos||head of department|