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Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction

A

AZ Sint-Jan AV

Status

Completed

Conditions

Orbital Fractures

Study type

Observational

Funder types

Other

Identifiers

NCT03057405
B049201731057

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

inclusion criteria

  • patients of all genders
  • patients of all ages
  • patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016

Trial design

22 participants in 3 patient groups

intra-operative CBCT
3D virtual planning + intra-operative navigation
3D virtual planning + intraoperative navigation + IO CBCT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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