CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap

CompletedOBSERVATIONAL
Enrollment

153

Participants

Timeline

Start Date

December 1, 2020

Primary Completion Date

March 1, 2021

Study Completion Date

April 18, 2021

Conditions
Operation TimeComplication of Surgical Procedure
Interventions
PROCEDURE

Computer-assisted surgery

Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness\<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.

Trial Locations (1)

Unknown

UZ Leuven, Leuven

All Listed Sponsors
lead

KU Leuven

OTHER

NCT04965441 - CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap | Biotech Hunter | Biotech Hunter