Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
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|ClinicalTrials.gov Identifier: NCT03054012|
Recruitment Status : Unknown
Verified February 2017 by Johan Abeloos, AZ Sint-Jan AV.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
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.
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
computer-assisted surgery group
- accuracy of planned and actual result, through segmentation of mandibles Brainlab software [ Time Frame: 6 months postoperative ]
- ischemia time [ Time Frame: perioperative ]
- financial implication [ Time Frame: preoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054012
|Principal Investigator:||Johan Abeloos||Head of department|