Oral cavity cancer Oral cancer
Conditions
Interventions
Mandibulectomy with fibula free flap reconstruction with the application of 3D printed surgery cutting guides and/or patient specific implants designed from MRI-based virtual bone models.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patient signed and dated informed consent prior to study-specific screening procedures 2) Oral cavity cancer or benign disease with planned segmental mandibulectomy and fibula free flap reconstruction 3) Age = 18 years
Exclusion criteria
Exclusion criteria: 1) Unable to undergo MRI scan (e.g. pacemaker present, claustrophobic) 2) Patient operated in acute setting 3) Patient is unable to speak or understand Dutch 4) Legally incapable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the number of patients successfully completing an MRI-only workflow for virtual surgical planning (VSP) in segmental mandibulectomy with fibula free flap reconstruction. This is defined as a segmental mandibulectomy with fibula free flap reconstruction using 3D printed cutting guides designed from MRI based models. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: 1) The accuracy of virtual bone models of the mandible, fibula and tibia generated from MRI data compared to those derived from CT data. 2) The weighted kappa in radiological artery anatomy and patency assessments between MRI and CT scans. 3) The incidence of 3D-printed cutting guides, based on MRI models, that do not fit appropriately during surgery. 4) the surgical accuracy, defined as the deviation (in mm) between the planned and achieved outcomes. This will be calculated by virtually aligning the 3D model of the post-operative cone beam CT (CBCT) scan with the MRI-based surgical plan. | — |
Countries
Netherlands
Contacts
Public ContactRSA Brink
Universitair Medisch Centrum Groningen
Outcome results
None listed