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NCT03057405 Clinical Trial

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

Orbital Fractures Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03057405
Other study ID # B049201731057
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date January 10, 2019

Study information
Verified date February 2019
Source AZ Sint-Jan AV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date January 10, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AZ Sint-Jan AV

Outcome
Type Measure Description Time frame Safety issue
Primary accuracy of orbital volume reconstruction, as measured in Brainlab immediate postoperative
See also
  Status Clinical Trial Phase
Terminated NCT03673865 - The Use of 3D Printing in Orbital Fractures N/A
Completed NCT00584506 - Computer Aided Evaluation of Orbital Volume N/A
Recruiting NCT03887988 - Orbital Fractures Registry
Not yet recruiting NCT04271137 - Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases N/A
Completed NCT02736461 - Factors Associated With Postoperative Strabismus After Floor Fracture Repair N/A
Completed NCT00233922 - Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant Phase 2
Withdrawn NCT01504568 - The Use of Prophylactic Antibiotics in Isolated Blowout Fractures N/A
Not yet recruiting NCT03813732 - Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures N/A
Recruiting NCT01464541 - Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan N/A
Completed NCT01432964 - Use of a Low Profile Titanium Mesh in Orbital Reconstruction N/A
Enrolling by invitation NCT06294535 - The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant N/A
Recruiting NCT04704414 - Exophthalmometry With 3D Face Scanners N/A
Completed NCT05439512 - Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach. N/A
Recruiting NCT06369129 - Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction N/A