Surgical EducationNCT06714539
Patient Specific Virtual Reality for Simulation of Spine Procedures: an Intelligent Image Segmentation, Registration and 3-dimensional Visualization in a Unified Virtual Reality Workflow for Image Guided Therapy, and Education - Physician Testing
A study testing Patient Specific Virtual Reality Stimulation in people with Surgical Education, run by Sunnybrook Health Sciences Centre.
Trial summary
The goal of this clinical trial is to learn if patient specific virtual reality (VR) simulations can be used for surgical orthopaedic education in resident and fellow physician populations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Education
- What is being tested?
- Patient Specific Virtual Reality Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any resident of fellow physician enrolled in the participating site's spine surgery training program.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if patient specific virtual reality (VR) simulations can be used for surgical orthopaedic education in resident and fellow physician populations.
Read the detailed description
This project will combine advanced 3d visualization, interaction, medical image segmentation, and registration to create and integrate a virtual reality (VR) model into surgical orthopaedic education. The work has 3 aspects,
- creating a patient specific 3D model with high accuracy of anatomic structures using patient specific medical imaging in an automated fashion, 2) interacting with 3D models of the patients, allowing the surgical procedures to be performed in virtual reality (including the resection of tissues, and placement of implants), 3) integrating the VR simulator into the surgical education of orthopaedic residents and fellows in training. This platform will reduce the time and cost associated with use of patient specific data, ultimately enabling pre-operative planning, post-procedural assessment and surgical simulation of spine procedures. The technology will improve surgical training, and the options for pre-treatment planning that will lead to better patient care, more efficient use of operating room time, and better trained surgeons.
- Conditions
- Surgical Education
- Being tested
- Patient Specific Virtual Reality Stimulation
- Keywords
- Surgical Education, Virtual Reality, Spine Surgery, Treatment Planning, Physician Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific Virtual Reality StimulationDevice
A novel virtual reality (VR) simulator for spine procedures that will take patient specific medical imaging (3D scans) and create a virtual patient that surgical procedures can be performed on.
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific Virtual Reality Stimulation | Experimental | Physician participants will engage with the patient specific virtual reality simulator through multi-player teaching and individual practice modes. Receives: Device: Patient Specific Virtual Reality Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.
Participants will complete study questionnaires before and after the testing sessions that ask them to list relevant structures involved in spinal decompression surgery. Participants will rate their confidence and motivation using the VR tool on a scale of 1 (highly confidence) to 10 (low confidence).
Measured: Up to 4 months for residents; up to 1 year for fellows
Secondary outcomes (2)
Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.
The performance of the pipeline will be measured by the total registration error, quantifying overlap of segmentation of structures, and the distance between landmarks.
Measured: Through study completion, an average of 5 years.
Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.
Orthopaedic residents and fellows will test the tool, following, they will fill out a questionnaire about the utility of the tool for learning and surgical planning. Participants will report their agreeableness to statements about the utility on a scale of 1 (strongly disagree) to 5 (strongly agree), and provide their own comments.
Measured: Through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Principal investigator, Michael Hardisty, Sunnybrook Health Sciences Centre
- Investigators
- Dr. Michael Hardisty, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714539
- Sponsor's protocol ID
- 6489
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As a non-FDA regulated trial the investigators are unsure how useful the data will be externally, but will post if there is interest.
Publications
Chen T, Zhang Y, Ding C, Ting K, Yoon S, Sahak H, Hope A, McLachlin S, Crawford E, Hardisty M, Larouche J, Finkelstein J. Virtual reality as a learning tool in spinal anatomy and surgical techniques. N Am Spine Soc J. 2021 Apr 14;6:100063. doi: 10.1016/j.xnsj.2021.100063. eCollection 2021 Jun.
PubMed 35141628
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Virtual Reality for Simulation of Spine Procedures: an Intelligent Image Segmentation, Registration and 3-dimensional Visualization in a Unified Virtual Reality Workflow for Image Guided Therapy, and Education - Physician Testing
- ClinicalTrials.gov ID
- NCT06714539
- Acronym / sponsor ID
- 6489
- Conditions
- Surgical Education
- Keywords
- Surgical Education, Virtual Reality, Spine Surgery, Treatment Planning, Physician Testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if patient specific virtual reality (VR) simulations can be used for surgical orthopaedic education in resident and fellow physician populations.
Detailed description
This project will combine advanced 3d visualization, interaction, medical image segmentation, and registration to create and integrate a virtual reality (VR) model into surgical orthopaedic education. The work has 3 aspects,
- creating a patient specific 3D model with high accuracy of anatomic structures using patient specific medical imaging in an automated fashion, 2) interacting with 3D models of the patients, allowing the surgical procedures to be performed in virtual reality (including the resection of tissues, and placement of implants), 3) integrating the VR simulator into the surgical education of orthopaedic residents and fellows in training. This platform will reduce the time and cost associated with use of patient specific data, ultimately enabling pre-operative planning, post-procedural assessment and surgical simulation of spine procedures. The technology will improve surgical training, and the options for pre-treatment planning that will lead to better patient care, more efficient use of operating room time, and better trained surgeons.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Specific Virtual Reality Stimulation | Experimental | Device: Patient Specific Virtual Reality StimulationPhysician participants will engage with the patient specific virtual reality simulator through multi-player teaching and individual practice modes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any resident of fellow physician enrolled in the participating site's spine surgery training program.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Specific Virtual Reality StimulationA novel virtual reality (VR) simulator for spine procedures that will take patient specific medical imaging (3D scans) and create a virtual patient that surgical procedures can be performed on. | Device | Patient Specific Virtual Reality Stimulation |
Primary outcome
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.
Time frame: Up to 4 months for residents; up to 1 year for fellows
Participants will complete study questionnaires before and after the testing sessions that ask them to list relevant structures involved in spinal decompression surgery. Participants will rate their confidence and motivation using the VR tool on a scale of 1 (highly confidence) to 10 (low confidence).
2 secondary outcomes
Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.
Time frame: Through study completion, an average of 5 years.
Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.
Time frame: Through study completion, an average of 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 35141628Chen T, Zhang Y, Ding C, Ting K, Yoon S, Sahak H, Hope A, McLachlin S, Crawford E, Hardisty M, Larouche J, Finkelstein J. Virtual reality as a learning tool in spinal anatomy and surgical techniques. N Am Spine Soc J. 2021 Apr 14;6:100063. doi: 10.1016/j.xnsj.2021.100063. eCollection 2021 Jun.
- Individual participant dataSharing planned: Undecided. As a non-FDA regulated trial the investigators are unsure how useful the data will be externally, but will post if there is interest.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Michael Hardisty principal investigator
Sunnybrook Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Patient Specific Virtual Reality Stimulation in people with Surgical Education, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Michael Hardisty (416-480-5790, m.hardisty@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation. (time frame: Up to 4 months for residents; up to 1 year for fellows). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06714539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.