Clinical trial NCT05429099: Mandibular Reconstruction Preplanning (ViPMR)
Official title: Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Oral Cavity Cancer
Oral Cancer
Keywords: Oral Cavity Cancer
Oral Cancer
Mandibular Reconstruction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both patient groups will receive the standard presurgical work-up including CT imaging, quality of life questionnaires, and a functional evaluation of bite force and jaw mobility.

Experimental arm - VSP: The trial research engineer (RE) will coordinate with the site surgeon (SS) to create and 3D-print surgical cutting guides for the mandible, for the fibula or scapula, and a 3D computed reconstruction. This reconstruction model will be used to pre-bend a titanium fixation plate. This plate and the surgical cutting guides will be sterilized prior to use. The SS will apply the mandibular cutting guide to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide will be applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized using blood vessels in the neck.

Control arm - FHS: In FHS, the SS will proceed with surgery as per their routine practice.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Bony Union
timeFrame: Assessed on CT scans 12 months postoperatively
Secondary outcomes:
measure: Difference in Intracondylar Distance
timeFrame: Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans
measure: Difference in Mandibular Angles
timeFrame: Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans
measure: University of Washington Quality of Life (UWQoL)
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: EQ-5D-5L Survey
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Dysphagia
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Oral Health
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Fibula harvest site complications
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Scapula harvest site complications
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Economic analysis
timeFrame: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Occlusal force (bite force)
timeFrame: Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)
measure: Dental Implantability
timeFrame: Up to 100 days after the post-operative CT scan.
measure: Operative Time
timeFrame: Initial Surgery
measure: Ischaemic Time
timeFrame: Initial Surgery
measure: Length of Stay
timeFrame: From date of patient's preoperative hospital admission until the date of hospital discharge postoperatively or date of death from any cause, whichever came first, assessed up to 100 days
measure: Rate of Plate Extrusion
timeFrame: Patients will be monitored for 1 year post-operatively
measure: Rate of Flap Failure
timeFrame: Patients will be monitored for 1 year post-operatively
measure: Rate of Cancer Reoccurrence
timeFrame: Patients will be monitored for 1 year post-operatively
measure: Adverse Events
timeFrame: Charts and interviews reviewed at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
measure: Occlusion
timeFrame: Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)
measure: Jaw Mobility
timeFrame: Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References: