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

NCT03054012 | Completed

• 1 other identifier: B0492017629990
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mandibular Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• accuracy of planned and actual result, through segmentation of mandibles Brainlab software

  6 months postoperative

Secondary Outcomes (2)

• ischemia time

  perioperative

• financial implication

  preoperative

Study Arms (1)

CAS group

computer-assisted surgery group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included

You may qualify if:

• 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

You may not qualify if:

• all patients not eligible according to abovementioned criteria

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

MeSH Terms

Conditions

Mandibular Injuries

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Johan Abeloos, MD

  Head of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share