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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-02-28

Brief Summary

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Background:

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.

Detailed Description

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Conditions

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Mandibular Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 all ages
* 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 patients not eligible according to abovementioned criteria
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Johan Abeloos

head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

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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