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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03054012

Enrollment

Registered

2017-02-15

Start date

2016-10-31

Completion date

2017-02-28

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Injuries

Keywords

CAD-CAM software, accuracy, head and neck region, mandibular reconstruction

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
accuracy of planned and actual result, through segmentation of mandibles Brainlab software	6 months postoperative

Secondary

Measure	Time frame
ischemia time	perioperative
financial implication	preoperative

Outcome results