Trials / Completed
CompletedNCT03057405
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 22 (actual)
- Sponsor
- AZ Sint-Jan AV · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2018-12-31
- Completion
- 2019-01-10
- First posted
- 2017-02-20
- Last updated
- 2019-02-15
Source: ClinicalTrials.gov record NCT03057405. Inclusion in this directory is not an endorsement.