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Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region

A

AZ Sint-Jan AV

Status

Completed

Conditions

Mandibular Injuries

Study type

Observational

Funder types

Other

Identifiers

NCT03054012
B0492017629990

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

CAS group
Description:
computer-assisted surgery group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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