420 Participants Needed

Virtual Surgical Planning vs. Free-Hand Surgery for Jaw Reconstruction in Oral Cancer Patients

(ViPMR Trial)

JK
EP
DP
Overseen ByDiane Pan
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Virtual Surgical Planning (VSP) safe for jaw reconstruction in humans?

The research does not provide specific safety data for Virtual Surgical Planning (VSP) or Free-Hand Surgery in jaw reconstruction, but VSP is widely used in maxillofacial surgery, suggesting it is generally considered safe.12345

How does Virtual Surgical Planning differ from Free-Hand Surgery for jaw reconstruction in oral cancer patients?

Virtual Surgical Planning (VSP) is unique because it allows surgeons to plan the surgery digitally before the actual procedure, which can improve accuracy and efficiency, reduce surgery time, and decrease stress for the surgeon. Unlike traditional free-hand surgery, VSP uses computer technology to create a detailed surgical plan, potentially leading to better outcomes.46789

What data supports the effectiveness of the treatment Virtual Surgical Planning (VSP) for jaw reconstruction in oral cancer patients?

Research shows that Virtual Surgical Planning (VSP) can significantly reduce operating time compared to traditional methods, and it is increasingly used in various surgeries, including jaw reconstruction, due to its accuracy and efficiency.48101112

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need jaw reconstruction due to oral cancer and can participate in the study. They must understand and consent to the trial, have a recent CT scan, and not have metastatic disease or a history of head/neck cancer or radiation within specified time frames.

Inclusion Criteria

I can understand and communicate about the trial effectively.
Patients who provide informed consent
I need surgery to remove part of my jaw and reconstruct it using bone from my leg or shoulder.
See 1 more

Exclusion Criteria

Pregnant or lactating women
I have had radiation treatment on my head or neck before.
I have severe health conditions alongside my cancer.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Virtual Surgical Planning (VSP) or Free-Hand Surgery (FHS) for mandibular reconstruction

Initial surgery
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of bony union and complication rates

12 months
6 visits (in-person)

Long-term Monitoring

Participants are monitored for long-term outcomes such as cancer recurrence and quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Free-Hand Surgery
  • Virtual Surgical Planning (VSP)
Trial Overview The trial compares Virtual Surgical Planning (VSP), which uses 3D models for surgery guides, with Free-Hand Surgery (FHS) as standard care. Patients are randomly assigned to either method to see which one results in better bone healing, fewer complications, more accurate reconstructions, improved quality of life, and functional outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Surgical Planning (VSP)Experimental Treatment1 Intervention
Group II: Free-Hand Surgery (FHS)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Published Research Related to This Trial

The introduction of Virtual Surgical Planning (VSP) has significantly increased the volume of orthognathic surgery research, with over 80.6% of relevant literature published after 2008, indicating its growing importance in surgical practices.
There is a notable difference in research output between OMS-trained and PRS-trained surgeons, with OMS-authored publications on VSP increasing at a much faster rate than those from PRS authors, highlighting differing focuses and approaches in the use of this technology.
The Impact of Virtual Surgical Planning on Orthognathic Surgery: Contributions From Two Specialties.Chen, J., Abousy, M., Girard, A., et al.[2022]
Using out of house virtual surgical planning (OH-VSP) for mandibular resection in oral cancer significantly reduced operating time compared to conventional methods (P<0.01).
Despite the time delay between planning and surgery, OH-VSP did not compromise the safety of the operation, as there were no significant differences in bony (P=0.49) or soft tissue (P=0.22) margin status.
'Out of house' virtual surgical planning for mandible reconstruction after cancer resection: is it oncologically safe?Barry, CP., MacDhabheid, C., Tobin, K., et al.[2021]
Virtual surgical planning (VSP) shows greater precision in predicting soft tissue outcomes and provides more symmetrical results in the frontal view compared to traditional surgical planning (TSP), based on a review of 5 randomized clinical trials involving 199 patients.
While VSP requires more time for initial software planning, it can save time in the overall preoperative process and has similar total costs to TSP, making it a viable alternative for orthognathic surgery.
A Meta-analysis and Systematic Review Comparing the Effectiveness of Traditional and Virtual Surgical Planning for Orthognathic Surgery: Based on Randomized Clinical Trials.Chen, Z., Mo, S., Fan, X., et al.[2021]

Citations

The Impact of Virtual Surgical Planning on Orthognathic Surgery: Contributions From Two Specialties. [2022]
'Out of house' virtual surgical planning for mandible reconstruction after cancer resection: is it oncologically safe? [2021]
A Meta-analysis and Systematic Review Comparing the Effectiveness of Traditional and Virtual Surgical Planning for Orthognathic Surgery: Based on Randomized Clinical Trials. [2021]
Institutional-based and commercial virtual surgical planning in maxillomandibular reconstruction - Comparing the digital plan and postoperative scan. [2022]
Virtual Surgical Planning: The Pearls and Pitfalls. [2022]
Time and cost-analysis of virtual surgical planning for head and neck reconstruction: A matched pair analysis. [2022]
Comparison of feasibility, time consumption and costs of three virtual planning systems for surgical correction of midfacial deficiency. [2021]
Evolution of surgical techniques for mandibular reconstruction using free fibula flaps: The next generation. [2022]
Is Virtual Surgical Planning in Orthognathic Surgery Faster Than Conventional Planning? A Time and Workflow Analysis of an Office-Based Workflow for Single- and Double-Jaw Surgery. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
In-House Surgeon-Led Virtual Surgical Planning for Maxillofacial Reconstruction. [2020]
The state of virtual surgical planning in maxillary Reconstruction: A systematic review. [2022]
Maxillofacial reconstruction using in-house virtual surgical planning. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity