NCT03057405

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

February 10, 2017

Last Update Submit

February 13, 2019

Conditions

Orbital Fractures

Keywords

intra-operative navigation3D virtual planningintra-operative cone beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (1)

  • accuracy of orbital volume reconstruction, as measured in Brainlab

    immediate postoperative

Study Arms (3)

intra-operative CBCT

3D virtual planning + intra-operative navigation

3D virtual planning + intraoperative navigation + IO CBCT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Officials

  • Johan Abeloos

    head of department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of department

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 20, 2017

Study Start

October 1, 2016

Primary Completion

December 31, 2018

Study Completion

January 10, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share