Mandibular Reconstruction Preplanning (ViPMR)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

October 15, 2022

Primary Completion Date

October 15, 2025

Study Completion Date

October 15, 2026

Conditions
Oral Cavity CancerOral Cancer
Interventions
PROCEDURE

Virtual Surgical Planning (VSP)

The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide is applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized by joining it to blood vessels in the neck.

PROCEDURE

Free-Hand Surgery

The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.

Trial Locations (1)

V5Z1M9

RECRUITING

Vancouver General Hospital, Vancouver

All Listed Sponsors
lead

University of British Columbia

OTHER