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

Mandibular Injuries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054012
• Other study ID #: B0492017629990
• Status: Completed
• Start date: October 2016
• Est. completion date: February 2017

Study information

• Verified date: January 2021
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mandibular Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of planned and actual result, through segmentation of mandibles Brainlab software		6 months postoperative
Secondary	ischemia time		perioperative
Secondary	financial implication		preoperative