Clinical trial · Interventional
Mandibular Reconstruction Preplanning (ViPMR)
Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Free-Hand Surgery | Procedure | — | UNRESOLVED |
| Virtual Surgical Planning (VSP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Free-Hand Surgery (FHS)
- description
- In FHS, the site surgeon will proceed with the surgery as per their routine practice.
- interventionNames
- Procedure: Free-Hand Surgery
- type
- EXPERIMENTAL
- label
- Virtual Surgical Planning (VSP)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTran 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