← Back to Search

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

Phase 2 & 3

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)

Awards & highlights

ViPMR Trial Summary

This trial will compare outcomes of patients who receive 3D-modeled surgery guides vs. current standard of care for cancer-related jaw reconstruction surgery. Bony union rates, complication rates, accuracy, QoL, and more will be measured.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't detailed here since it's about surgical techniques rather than drugs, potential risks may include typical surgical complications such as infection risk at the site of surgery, bleeding issues during or after surgery, nerve damage leading to numbness or motor function loss around operated areas.

ViPMR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery to remove part of my jaw and reconstruct it using bone from my leg or shoulder.

ViPMR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bony Union

Secondary outcome measures

Adverse Events

Dental Implantability

Difference in Intracondylar Distance

+17 more

ViPMR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Surgical Planning (VSP)Experimental Treatment1 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 Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,698 Total Patients Enrolled

3 Trials studying Oral Cancers

680 Patients Enrolled for Oral Cancers

Media Library

Free-Hand Surgery Clinical Trial Eligibility Overview. Trial Name: NCT05429099 — Phase 2 & 3

Oral Cancers Research Study Groups: Free-Hand Surgery (FHS), Virtual Surgical Planning (VSP)

Oral Cancers Clinical Trial 2023: Free-Hand Surgery Highlights & Side Effects. Trial Name: NCT05429099 — Phase 2 & 3

Free-Hand Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429099 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current headcount of participants in this clinical trial?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial is currently open for recruitment, which began on October 15th 2022 and was last modified on June 5th 2023. This research seeks 420 volunteers from a single facility."

Answered by AI

Are there still opportunities for participants in this examination?

"Correct. Clinicaltrials.gov confirms that this medical trial, which went live on 15th October 2022, is actively recruiting patients. 420 people are required to be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mandibular Reconstruction Preplanning (ViPMR)

Eitan Prisman 2022. "Mandibular Reconstruction Preplanning (ViPMR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429099.