Virtual RealityNCT04302298
The Role of Virtual Reality in Orthopaedic Surgery Education
A study testing Virtual Reality in people with Virtual Reality and Surgical Training, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Virtual reality (VR) and augmented reality are becoming prominent in the medical sciences due to the increasing sophistication of VR technology and its improving haptics to simulate real-life situations. Read more about this study
- Who is it for?
- Ages 20 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Surgical Training
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1st or 2nd year medical students at University of Illinois at Chicago College of Medicine
Who cannot join
- if they had done or ever seen a tibial nail procedure in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Medicine
Chicago, Illinois, 60611
About this study
Official title: The Role of Virtual Reality in Orthopaedic Surgery Education: A Randomized Control Trial
Virtual reality (VR) and augmented reality are becoming prominent in the medical sciences due to the increasing sophistication of VR technology and its improving haptics to simulate real-life situations. Previous medical VR studies focused on arthroscopic minimally-invasive procedures which often do not carry the risk of invasive procedures. OssoVR, an orthopedic surgery virtual reality company, has created a platform to run through different invasive orthopedic procedures prior to operating on a patient. Given that invasive procedures inherently carry more risk and variability than minimally invasive procedures, training tools to help with these operations are vital prior to performing on a patient. The research team will evaluate the face validity, transfer validity, and surgical recall of the orthopedic virtual reality software in an intramedullary (IM) tibial nail procedure. The research team will evaluate the simulation with medical students who have not had prior exposure to the procedure. Including medical students will allow for a larger sample size for more analysis. An IM tibial nail procedure is used in tibial fractures to help stabilize the fractured long bone via placement of a nail within the bone.
Read the detailed description
Virtual reality has the potential to make a significant impact on medical education at both the medical student and resident level. OssoVR is one of the first companies that has produced functioning software for this niche student group. Medical students gain intimate knowledge regarding the musculoskeletal system helpful for the board exam and a unique insight into procedures they will see during clerkship. This offers them a larger potential to learn when seeing the procedure in the OR, and a view of orthopedic surgery they might not have if they decide to go into other specialties. Testing its efficacy on medical students will help reveal whether or not it may be helpful to have residents use virtual reality rather than reading a step-by-step guide, which is currently the norm for residents after observing the procedure performed by an attending. There is strong agreement in the literature that simulation technology should be a required part of orthopedic residence training (5) and that it improves resident surgical performance. The study was limited to medical students due to the limited number of orthopedic residents at UIC that have not seen an IM tibial nail procedure.
Objectives/Aims
Aim I. Test the procedural competence of the VR versus the step-by-step guide of IM tibial nail. I will have all of the students go through the procedure on SawBones separately. SawBones are artificial bones used to help train orthopedic students on how to perform a surgery prior to performing the surgery. To ensure blinding, Dr. Gonzalez evaluate their performance as he is a professional in orthopedic surgery and has the appropriate background for proper evaluation of accuracy. He will evaluate their time to complete the procedure, their accuracy in following the steps, and their OSATS score which is used to evaluate surgical technical skills.
Aim II. Evaluate how the students who completed the VR simulation felt regarding it. After going through the tibial nail simulation, the students will take a subjective survey regarding how they felt about the experience adapted from a current questionnaire used for virtual environment experiences .
- Conditions
- Virtual Reality, Surgical Training
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
A machine which immerses the participant in a simulated environment where they can perform a procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | This group will go through the virtual reality simulation of a procedure prior to doing it on a plastic SawBone. Receives: Device: Virtual Reality |
| Technique Guide Group | No intervention | This group will go be able to read through a technique guide on the procedure prior to doing it on a plastic SawBone. This is the current method of learning in surgical residencies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
Which participants completed the SawBones procedure
Measured: day 10-14
Secondary outcomes (2)
Number of Steps Performed Correctly - Accuracy
How many steps did the subject follow as designated in the technique guide/virtual reality?
Measured: Within 25 minutes
Time of Completion
How quickly did each participant complete the surgical procedure, if completed it all?
Measured: up to 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start20 Aug 2019
- Primary completion25 Sep 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark H Gonzalez, University of Illinois Chicago
- Investigators
- Mark H Gonzalez, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302298
- Sponsor's protocol ID
- 2019-0335
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Virtual Reality in Orthopaedic Surgery Education: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04302298
- Acronym / sponsor ID
- 2019-0335
- Conditions
- Virtual Reality, Surgical Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 10 Mar 2020 (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.
Virtual reality (VR) and augmented reality are becoming prominent in the medical sciences due to the increasing sophistication of VR technology and its improving haptics to simulate real-life situations. Previous medical VR studies focused on arthroscopic minimally-invasive procedures which often do not carry the risk of invasive procedures. OssoVR, an orthopedic surgery virtual reality company, has created a platform to run through different invasive orthopedic procedures prior to operating on a patient. Given that invasive procedures inherently carry more risk and variability than minimally invasive procedures, training tools to help with these operations are vital prior to performing on a patient. The research team will evaluate the face validity, transfer validity, and surgical recall of the orthopedic virtual reality software in an intramedullary (IM) tibial nail procedure. The research team will evaluate the simulation with medical students who have not had prior exposure to the procedure. Including medical students will allow for a larger sample size for more analysis. An IM tibial nail procedure is used in tibial fractures to help stabilize the fractured long bone via placement of a nail within the bone.
Detailed description
Virtual reality has the potential to make a significant impact on medical education at both the medical student and resident level. OssoVR is one of the first companies that has produced functioning software for this niche student group. Medical students gain intimate knowledge regarding the musculoskeletal system helpful for the board exam and a unique insight into procedures they will see during clerkship. This offers them a larger potential to learn when seeing the procedure in the OR, and a view of orthopedic surgery they might not have if they decide to go into other specialties. Testing its efficacy on medical students will help reveal whether or not it may be helpful to have residents use virtual reality rather than reading a step-by-step guide, which is currently the norm for residents after observing the procedure performed by an attending. There is strong agreement in the literature that simulation technology should be a required part of orthopedic residence training (5) and that it improves resident surgical performance. The study was limited to medical students due to the limited number of orthopedic residents at UIC that have not seen an IM tibial nail procedure.
Objectives/Aims
Aim I. Test the procedural competence of the VR versus the step-by-step guide of IM tibial nail. I will have all of the students go through the procedure on SawBones separately. SawBones are artificial bones used to help train orthopedic students on how to perform a surgery prior to performing the surgery. To ensure blinding, Dr. Gonzalez evaluate their performance as he is a professional in orthopedic surgery and has the appropriate background for proper evaluation of accuracy. He will evaluate their time to complete the procedure, their accuracy in following the steps, and their OSATS score which is used to evaluate surgical technical skills.
Aim II. Evaluate how the students who completed the VR simulation felt regarding it. After going through the tibial nail simulation, the students will take a subjective survey regarding how they felt about the experience adapted from a current questionnaire used for virtual environment experiences .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual RealityThis group will go through the virtual reality simulation of a procedure prior to doing it on a plastic SawBone. |
| Technique Guide Group | No intervention | –This group will go be able to read through a technique guide on the procedure prior to doing it on a plastic SawBone. This is the current method of learning in surgical residencies. |
Who may qualify
- Ages
- 20 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1st or 2nd year medical students at University of Illinois at Chicago College of Medicine
Key exclusion criteria (1 listed)
- if they had done or ever seen a tibial nail procedure in the past
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 |
|---|---|---|
| Virtual RealityA machine which immerses the participant in a simulated environment where they can perform a procedure. | Device | Virtual Reality Group |
Primary outcome
Completion Rate
Time frame: day 10-14
Which participants completed the SawBones procedure
2 secondary outcomes
Number of Steps Performed Correctly - Accuracy
Time frame: Within 25 minutes
Time of Completion
Time frame: up to 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mark H Gonzalez, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Virtual Reality and Surgical Training, run by University of Illinois Chicago at 1 site in United States.
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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (time frame: day 10-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.