Recruiting

Mandibular Reconstruction

Sponsor:

University of British Columbia

Code:

NCT05429099

Conditions

Oral Cavity Cancer

Oral Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Surgical Planning (VSP)

Free-Hand Surgery

Study Details

Brief summary:

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.

Conditions

Oral Cavity Cancer

Oral Cancer

Study ID

NCT05429099

Start date

Oct 15, 2022

Status verified date

Sep, 2026

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Free-Hand Surgery (FHS)

In FHS, the site surgeon will proceed with the surgery as per their routine practice.

experimental: Virtual Surgical Planning (VSP)

The trial research engineer (RE), located at Vancouver General Hospital (VGH), will segment the CT data to create a 3D model for surgical planning. During the teleconference between site surgeon (SS) and RE, the RE will load the CT data and the segmented 3D model into the virtual planning environment. With the RE navigating the software, which was created in-house at VGH and used in a previous case series, the SS will determine the extent of disease and define the resection planes. After the cutting planes are created, the RE will use the software to create the reconstruction plan with either the patient-specific fibula or scapula. Once the surgeon is satisfied with the plan, the teleconference will end and the RE will create and 3D print the surgical guides for the mandible, for the fibula or scapula, as well as the 3D computed reconstruction.

Interventions

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.

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.

Primary outcome measure

  • Bony Union [ Time Frame: Assessed on CT scans 12 months postoperatively ]

Central Contacts and Locations

Central contacts

Eitan Prisman, MD, FRCSC

6048754126eitan.prisman@ubc.ca

Mathew Fu

6048754111mfu08@student.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Eitan Prisman, MD MA FRCSC

6048754126eitan.prisman@ubc.ca

Mathew Fu

6048754111mfu08@student.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Oral Cavity Cancer
  • Oral Cancer
  • Mandibular Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-09-08.