Clinical Trials Directory

Trials / Completed

CompletedNCT03054012

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
AZ Sint-Jan AV · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

Timeline

Start date
2016-10-01
Primary completion
2017-02-01
Completion
2017-02-01
First posted
2017-02-15
Last updated
2021-01-19

Source: ClinicalTrials.gov record NCT03054012. Inclusion in this directory is not an endorsement.