Brief Title
Mandibular Reconstruction Preplanning (ViPMR)
Official Title
Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
Brief Summary
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Bony Union
Secondary Outcome
Difference in Intracondylar Distance
Condition
Oral Cavity Cancer
Intervention
Virtual Surgical Planning (VSP)
Study Arms / Comparison Groups
Free-Hand Surgery (FHS)
Description: In FHS, the site surgeon will proceed with the surgery as per their routine practice.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
315
Start Date
September 1, 2022
Completion Date
September 1, 2026
Primary Completion Date
September 1, 2025
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 6048754126, [email protected]
Administrative Informations
NCT ID
NCT05429099
Organization ID
H20-03314
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Study Sponsor
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Verification Date
June 2022