Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03054012
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2017-02-13
Brief Title:
Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
Sponsor:
AZ Sint-Jan AV
Organization:
AZ Sint-Jan AV
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prebending 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
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 prebending 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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None