Mandibular Reconstruction Preplanning (ViPMR)

NCT05429099 | Recruiting Phase 2

• 1 other identifier: H20-03314
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cavity Cancer; Oral Cancer

Keywords

Oral Cavity Cancer; Oral Cancer; Mandibular Reconstruction

Outcome Measures

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.

  Assessed on CT scans 12 months postoperatively

Secondary Outcomes (20)

• Difference in Intracondylar Distance

  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

  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)

  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

  Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)

• Dysphagia

  Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)

Study Arms (2)

Free-Hand Surgery (FHS)

ACTIVE COMPARATOR

In FHS, the site surgeon will proceed with the surgery as per their routine practice.

Procedure: Free-Hand Surgery

Virtual Surgical Planning (VSP)

EXPERIMENTAL

The trial research engineer (RE), located at Vancouver General Hospital (VGH), will segment the CT data to create a 3D model for surgical planning. During the teleconference between site surgeon (SS) and RE, the RE will load the CT data and the segmented 3D model into the virtual planning environment. With the RE navigating the software, which was created in-house at VGH and used in a previous case series, the SS will determine the extent of disease and define the resection planes. After the cutting planes are created, the RE will use the software to create the reconstruction plan with either the patient-specific fibula or scapula. Once the surgeon is satisfied with the plan, the teleconference will end and the RE will create and 3D print the surgical guides for the mandible, for the fibula or scapula, as well as the 3D computed reconstruction.

Procedure: Virtual Surgical Planning (VSP)

Interventions

Virtual Surgical Planning (VSP) PROCEDURE

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 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.

Virtual Surgical Planning (VSP)

Free-Hand Surgery PROCEDURE

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.

Free-Hand Surgery (FHS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Related Publications (1)

• 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 compare the efficacy of Virtual Surgical Planning (VSP) to Freehand Surgery (FHS) on bony union and quality of life outcomes for mandibular reconstruction with fibular and scapular free flaps: study protocol for a randomized phase II/III trial. BMC Cancer. 2025 Feb 27;25(1):358. doi: 10.1186/s12885-025-13505-5.

  PMID: 40016641 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Eitan Prisman, MD, FRCSC

CONTACT

6048754126; eitan.prisman@ubc.ca

Tayo Steininger

CONTACT

6048754111; tstein12@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 23, 2022
• Study Start: October 15, 2022
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 15, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CA (1)