NCT04302298

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

February 11, 2020

Last Update Submit

March 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Completion Rate

    Which participants completed the SawBones procedure

    day 10-14

Secondary Outcomes (2)

  • Number of Steps Performed Correctly - Accuracy

    Within 25 minutes

  • Time of Completion

    up to 25 minutes

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

This group will go through the virtual reality simulation of a procedure prior to doing it on a plastic SawBone.

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.

Interventions

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

Virtual Reality Group

Eligibility Criteria

Age20 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago College of Medicine

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Mark H Gonzalez, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Medical students will be recruited via an email which asks them to participate in the trial. Those who respond will be randomly assigned into the virtual reality or technique guide group, and thus know which group they are a part of. They will be randomly assigned into these groups using a number generator of 1 or 2 for the virtual reality and technique guide group, respectively. An equal amount of participants will be allocated to each group. Following completion of the experiment, the attending physician evaluating their performance will be blinded to which group they were in as well as the gender of the participant to eliminate any bias.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Chair of the Department of Orthopaedics

Study Record Dates

First Submitted

February 11, 2020

First Posted

March 10, 2020

Study Start

August 20, 2019

Primary Completion

September 25, 2019

Study Completion

November 18, 2019

Last Updated

March 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations