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Mandibular Reconstruction Preplanning (ViPMR)

Sponsor: University of British Columbia • ClinicalTrials.gov ID: NCT05429099

Registry updated: 2026-09-08

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Description

Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.

Interventions

Virtual Surgical Planning (VSP) (Procedure)
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.
Free-Hand Surgery (Procedure)
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.

Eligibility criteria

Inclusion Criteria: * primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery * are over the age of 18 * cognitive ability and language skills that allow participation in the trial * provide informed consent Exclusion Criteria: * severe comorbidities including metastatic disease * do not have a recent (within 30 days) CT scan and are unable/unwilling to receive a head CT scan at the latest 6 days prior to surgery * prior history of head or neck cancer within last 5 years * prior history of head or neck radiation treatment at any time * pregnant of lactating women

Conditions

Oral Cavity Cancer Oral Cancer

Locations

Vancouver General Hospital — Vancouver, British Columbia, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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