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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04302298
Other study ID # 2019-0335
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2019
Est. completion date November 18, 2019

Study information

Verified date February 2020
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 18, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 27 Years
Eligibility Inclusion Criteria:

- 1st or 2nd year medical students at University of Illinois at Chicago College of Medicine

Exclusion Criteria:

- if they had done or ever seen a tibial nail procedure in the past

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual Reality
A machine which immerses the participant in a simulated environment where they can perform a procedure.

Locations

Country Name City State
United States University of Illinois at Chicago College of Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion Rate Which participants completed the SawBones procedure day 10-14
Secondary Number of Steps Performed Correctly - Accuracy How many steps did the subject follow as designated in the technique guide/virtual reality? Within 25 minutes
Secondary Time of Completion How quickly did each participant complete the surgical procedure, if completed it all? up to 25 minutes
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