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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057405
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Johan Abeloos, AZ Sint-Jan AV

Brief Summary:

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
Orbital Fractures

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. accuracy of orbital volume reconstruction, as measured in Brainlab [ Time Frame: immediate postoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Johan Abeloos head of department
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Responsible Party: Johan Abeloos, head of department, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03057405    
Other Study ID Numbers: B049201731057
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Abeloos, AZ Sint-Jan AV:
intra-operative navigation
3D virtual planning
intra-operative cone beam computed tomography (CBCT)
Additional relevant MeSH terms:
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Orbital Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries