Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
NCT ID: NCT03054012
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2016-10-31
2017-02-28
Brief Summary
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Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.
Study design:
Retrospective study.
All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CAS group
computer-assisted surgery group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patients of both genders
* patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
* all patients undergoing bony reconstruction by free vascularised flap
* all patients treated between January 2013 and August 2016
* all patients where CAS was applied
Exclusion Criteria
ALL
No
Sponsors
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AZ Sint-Jan AV
OTHER
Responsible Party
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Johan Abeloos
head of department
Principal Investigators
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Johan Abeloos, MD
Role: PRINCIPAL_INVESTIGATOR
Head of department
Other Identifiers
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B0492017629990
Identifier Type: -
Identifier Source: org_study_id
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