Mandibular Reconstruction Preplanning (ViPMR)

University of British Columbia

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Oral Cavity Cancer; Oral Cancer

Treatments: Procedure: Free-Hand Surgery; Procedure: Virtual Surgical Planning (VSP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05429099

H20-03314

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups

Free-Hand Surgery (FHS)

Active Comparator group

Description:

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

Treatment:

Procedure: Free-Hand Surgery

Virtual Surgical Planning (VSP)

Experimental group

Description:

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.

Treatment:

Procedure: Virtual Surgical Planning (VSP)