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

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.

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.

Study Overview

• Status: Completed
• Conditions: Orbital Fractures

• Study Type: Observational
• Enrollment (Actual): 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016

Description

inclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
accuracy of orbital volume reconstruction, as measured in Brainlab	immediate postoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Johan Abeloos, Head of Department

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: intra-operative navigation; 3D virtual planning; intra-operative cone beam computed tomography (CBCT)
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Orbital Fractures
• Other Study ID Numbers: B049201731057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No