Mandibular Reconstruction Preplanning (ViPMR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Surgical Planning (VSP), Free-Hand Surgery.
- Who it may be relevant to
- Registry conditions: Oral Cavity Cancer, Oral Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure Virtual Surgical Planning (VSP)
The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide - Procedure Free-Hand Surgery
The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.
Primary outcome measures
- Bony Union [Time frame: Assessed on CT scans 12 months postoperatively]
Secondary outcome measures (12)
- Difference in Intracondylar Distance [Time frame: Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans]
- Difference in Mandibular Angles [Time frame: Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans]
- University of Washington Quality of Life (UWQoL) [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- EQ-5D-5L Survey [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Dysphagia [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Oral Health [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Fibula harvest site complications [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Scapula harvest site complications [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Economic analysis [Time frame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
- Occlusal force (bite force) [Time frame: Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)]
- Dental Implantability [Time frame: Up to 100 days after the post-operative CT scan.]
- Operative Time [Time frame: Initial Surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Vancouver General Hospital — Vancouver
Publications
- Tran KL, Turkdogan S, Dinur AB, Milner TD, Wang E, Nichols A, MacNeil D, Mendez A, Jervis-Bardy J, De Almeida J, Yao C, Goldstein D, Gilbert R, Eskander A, Higgins K, Enepekides D, Gupta M, Zhang H, Au M, Nguyen S, Fels S, Hodgson A, Brasher P, Mitton C, Sabiq F, Fisher C, Yang D, Wong A, Garnis C, Poh C, Durham JS, Prisman E. A multi-centre, participant-blinded, randomized, 3-year study to compar PMID 40016641
Identifiers
NCT: NCT05429099 · H20-03314