Actively Recruiting
Mandibular Reconstruction Preplanning (ViPMR)
Led by University of British Columbia · Updated on 2025-07-24
420
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Mandibular Reconstruction Preplanning (ViPMR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery
- Age 18 years or older
- Cognitive ability and language skills to participate in the trial
- Provide informed consent
You will not qualify if you...
- Severe comorbidities including metastatic disease
- No recent (within 30 days) CT scan and unable or unwilling to have a head CT scan within 6 days before surgery
- Prior head or neck cancer within the last 5 years
- Prior head or neck radiation treatment at any time
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
Research Team
E
Eitan Prisman, MD, FRCSC
CONTACT
T
Tayo Steininger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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