Clinical Trial: Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title:
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 Summary:
Sponsor: AZ Sint-Jan AV
Current Primary Outcome: accuracy of planned and actual result, through segmentation of mandibles Brainlab software [ Time Frame: 6 months postoperative ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ischemia time [ Time Frame: perioperative ]
- financial implication [ Time Frame: preoperative ]
Original Secondary Outcome: Same as current
Information By: AZ Sint-Jan AV
Dates:
Date Received: February 13, 2017
Date Started: October 2016
Date Completion: June 2017
Last Updated: February 14, 2017
Last Verified: February 2017
