Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05429099

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z1M9

Actively Recruiting

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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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