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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Johan Abeloos, AZ Sint-Jan AV

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.


Condition or disease
Mandibular Injuries

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Actual Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Group/Cohort
CAS group
computer-assisted surgery group



Primary Outcome Measures :
  1. accuracy of planned and actual result, through segmentation of mandibles Brainlab software [ Time Frame: 6 months postoperative ]

Secondary Outcome Measures :
  1. ischemia time [ Time Frame: perioperative ]
  2. financial implication [ Time Frame: preoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Johan Abeloos Head of department
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Responsible Party: Johan Abeloos, head of department, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03054012    
Other Study ID Numbers: B0492017629990
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Abeloos, AZ Sint-Jan AV:
CAD-CAM software
accuracy
head and neck region
mandibular reconstruction
Additional relevant MeSH terms:
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Mandibular Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries