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

(ViPMR Trial)

Overseen By Tayo Steininger

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of British Columbia

Disqualifiers: Metastatic disease, Recent head cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: Initial surgery

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of jaw reconstruction surgery for oral cancer: Virtual Surgical Planning (VSP) and Free-Hand Surgery (FHS). VSP uses 3D modeling and printing to create surgical guides, while FHS depends on the surgeon's skill without these aids. The main goal is to determine which method leads to better recovery and fewer complications post-surgery. Candidates for this trial include those needing jaw surgery due to cancer and who have had a recent CT scan. As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to advance surgical care.

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.

What prior data suggests that Virtual Surgical Planning is safe for jaw reconstruction in oral cancer patients?

Research has shown that Virtual Surgical Planning (VSP) holds promise for safety. Studies have found that VSP enhances surgical precision, potentially leading to fewer complications and a safer process overall. Specifically, research on VSP for jaw reconstruction indicates it reduces surgery time and provides more accurate results.

Although data on side effects is limited, the technology aims to make surgeries less invasive, often resulting in fewer risks for patients. So far, similar procedures have not reported major safety concerns.

This suggests VSP is generally well-tolerated, but every medical treatment can carry risks. Always discuss potential side effects and safety concerns with the trial team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these techniques because they offer new ways to approach jaw reconstruction in oral cancer patients. Unlike standard free-hand surgery, which relies heavily on the surgeon's skill and experience to plan and execute the reconstruction, Virtual Surgical Planning (VSP) uses advanced 3D modeling and printing technology. VSP allows for precise pre-surgical planning using a computer-generated model of the patient's anatomy, potentially leading to more accurate and personalized surgical outcomes. This method not only enhances surgical precision but also aims to reduce operation time and improve recovery, which are significant benefits over current free-hand methods.

What evidence suggests that Virtual Surgical Planning is effective for jaw reconstruction in oral cancer patients?

Research has shown that Virtual Surgical Planning (VSP), a treatment option in this trial, increases surgical accuracy and reduces operating room time compared to traditional methods. Studies have found that VSP uses 3D models and printing to help surgeons plan more precisely, leading to more predictable outcomes, with results being more consistent and reliable. Although VSP might not shorten hospital stays, it enhances the surgeon's ability to achieve desired results. Overall, VSP is transforming jaw reconstruction surgery and is considered more effective than Free-Hand Surgery (FHS), the other treatment option in this trial, for these reasons. ^{3 4 6 7 8}

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.

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.

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?

Group I: Virtual Surgical Planning (VSP) Experimental Treatment 1 Intervention

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.

Group II: Free-Hand Surgery (FHS) Active Control 1 Intervention

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

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

All three virtual surgical planning software applications (IPS Case Designer®, Dolphin Imaging®, and ProPlan CMF®) are effective for planning modified intraoral quadrangular Le Fort II osteotomy (IQLFIIO) and producing surgical splints using CAD/CAM technology.

Dolphin Imaging® was the quickest software to use, taking an average of 33.6 minutes, while ProPlan CMF® took longer at 45.5 minutes, indicating that while all software is usable, there are differences in efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of feasibility, time consumption and costs of three virtual planning systems for surgical correction of midfacial deficiency. Willinger, K., Guevara-Rojas, G., Cede, J., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 76 patients undergoing virtual surgical planning (VSP) for mandible reconstruction using free fibula flaps showed that VSP has enabled more complex and innovative surgical techniques without increasing operative times or complications.

The use of VSP has led to improved functional and aesthetic outcomes in mandible reconstructions, as evidenced by significant advancements in the number of segments and components used in the flaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of surgical techniques for mandibular reconstruction using free fibula flaps: The next generation. Monaco, C., Stranix, JT., Avraham, T., et al.[2022]

Virtual surgical planning (VSP) significantly reduced the working time for both single-jaw and double-jaw orthognathic surgeries compared to conventional surgical planning (CSP), with mean time reductions of approximately 36.2% for single-jaw and 33.3% for double-jaw surgeries.

The surgeon's time investment remained similar between VSP and CSP, indicating that while VSP streamlines the overall workflow, it does not increase the surgeon's planning time, making it an efficient alternative for surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Steinhuber, T., Brunold, S., Gärtner, C., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'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) for maxillomandibular reconstruction is accurate, with mean errors of only 1.7 mm for intergonial distances and 1.3 mm for segment lengths, based on a study of 44 patients.

In-house VSP shows similar accuracy to commercial VSP methods, suggesting that it can be a cost-effective alternative, although more complex cases, especially those involving osteoradionecrosis, may lead to higher inaccuracies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institutional-based and commercial virtual surgical planning in maxillomandibular reconstruction - Comparing the digital plan and postoperative scan. Johal, M., Ma, JNB., Parthasarathi, K., et al.[2022]

Virtual surgical planning (VSP) has gained popularity in head and neck reconstruction, particularly for maxillary and mid-facial procedures, but there is currently no large-scale randomized control trial to confirm its benefits over traditional freehand surgery.

A review of 16 studies involving 142 patients revealed significant inconsistencies in how outcomes were reported, indicating a lack of standardized measures and highlighting the need for future randomized trials to validate the efficacy of VSP in maxillary reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of virtual surgical planning in maxillary Reconstruction: A systematic review. Chan, TJ., Long, C., Wang, E., et al.[2022]

Virtual surgical planning (VSP) technology significantly reduces the median length of hospital stay and procedure time for complex facial reconstructions, with a median stay of 10 days compared to 13 days for non-VSP cases.

Despite the higher complexity of cases treated with VSP, the overall treatment costs remained similar, indicating that VSP can enhance surgical efficiency without increasing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time and cost-analysis of virtual surgical planning for head and neck reconstruction: A matched pair analysis. Mazzola, F., Smithers, F., Cheng, K., et al.[2022]

In-house virtual surgical planning (VSP) for mandibular and maxillary reconstruction using fibula free flaps is feasible and can be performed without external resources, demonstrating low cost and efficient turnaround times.

The use of VSP in this preliminary case series of six patients led to improved surgical efficiency, suggesting that it can reduce operative times and surgeon stress during complex reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maxillofacial reconstruction using in-house virtual surgical planning. Smithers, FAE., Cheng, K., Jayaram, R., et al.[2022]

A study of 54 virtual surgeries at the University of Montreal showed that 85% of orthognathic surgery plans were fully adhered to, indicating high efficacy in using virtual surgical planning (VSP) for craniofacial procedures.

However, 25% of free tissue transfer surgeries had partial adherence to virtual plans, highlighting challenges such as communication issues and anatomical assessment that surgeons need to consider when using VSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Surgical Planning: The Pearls and Pitfalls. Efanov, JI., Roy, AA., Huang, KN., et al.[2022]

The in-house virtual surgical planning (VSP) technique for maxillofacial reconstruction was successfully implemented in 19 patients, demonstrating a simple and repeatable process that took an average of 158 minutes to complete.

This method significantly reduces costs, with an average of $5.21 CAD for printing the reconstructed jaw model and $12.80 CAD for the cutting guides, making it an efficient option for surgeons without engineering expertise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-House Surgeon-Led Virtual Surgical Planning for Maxillofacial Reconstruction. Abo Sharkh, H., Makhoul, N.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Surgical Planning on Orthognathic Surgery: Contributions From Two Specialties. Chen, J., Abousy, M., Girard, A., et al.[2022]

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