Mandibular Reconstruction Preplanning (ViPMR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Virtual Surgical Planning (VSP)
- Free-Hand Surgery
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov