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

Completed

• Conditions: Mandibular Injuries

• Registration Number: NCT03054012
• Lead Sponsor: AZ Sint-Jan AV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
financial implication	preoperative
ischemia time	perioperative