Mandibular Reconstruction Preplanning (ViPMR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Surgical Planning (VSP)
Procedure/SurgeryThe 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 to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide is applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized by joining it to blood vessels in the neck.
Free-Hand Surgery
Procedure/SurgeryThe 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.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Free-Hand Surgery (FHS)Active comparator 1 intervention
Group B: Virtual Surgical Planning (VSP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bony Union
The primary outcome is nonunion as assessed by two independent radiologists at Vancouver General Hospital, blinded to the intervention, based on the 12-month postoperative CT scan. Each apposition (between native bone-flap or between flap segments) will be assessed as nonunion, partial union, and complete union. Cases where there is disagreement between reviewers will undergo consensus review, any persisting disagreements will be reviewed by a third radiologist and classification will be based on the majority vote.
Time frame
Assessed on CT scans 12 months postoperativelySecondary outcomes
1
Difference in Intracondylar Distance
Comparison to assess structural reconstruction accuracy of postoperative versus preoperative cephalometrics. This will be calculated as the absolute value of postoperative intracondylar distance minus preoperative intercondylar distance (millimeters).
Time frame
Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans2
Difference in Mandibular Angles
Comparison to assess structural reconstruction accuracy of postoperative versus preoperative cephalometrics. This will calculated as the absolute value of postoperative mandibular angle minus preoperative mandibular angle (degrees).
Time frame
Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans3
University of Washington Quality of Life (UWQoL)
A questionnaire that measures quality of life which records responses on the 5-point Likert scale; minimum of 1 (strongly disagree) and maximum of 5 (strongly agree).
Time frame
Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)4
EQ-5D-5L Survey
Another questionnaire which measures quality of life. Responses recorded as checkboxes that are ticked if applicable to the participant. Participant health is measured on a scale of 0 (worst health imaginable) to 100 (best health imaginable).
Time frame
Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)Sponsors and contacts
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Source ClinicalTrials.gov