Mandibular Reconstruction Preplanning (ViPMR)

Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial

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.

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