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

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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

Tracking Information
First Submitted Date February 10, 2017
First Posted Date February 20, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date October 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2017)
accuracy of orbital volume reconstruction, as measured in Brainlab [ Time Frame: immediate postoperative ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
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.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016
Condition Orbital Fractures
Intervention Not Provided
Study Groups/Cohorts
  • intra-operative CBCT
  • 3D virtual planning + intra-operative navigation
  • 3D virtual planning + intraoperative navigation + IO CBCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2019)
22
Original Estimated Enrollment
 (submitted: February 15, 2017)
40
Actual Study Completion Date January 10, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03057405
Other Study ID Numbers B049201731057
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johan Abeloos, AZ Sint-Jan AV
Study Sponsor AZ Sint-Jan AV
Collaborators Not Provided
Investigators
Principal Investigator: Johan Abeloos head of department
PRS Account AZ Sint-Jan AV
Verification Date February 2019