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VR Simulation and Basic Skills in THA (MD-VR-THA)

Primary Purpose

Educational Problems, Hip Arthroplasty, Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
VR simulation on basic THA skills
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Educational Problems focused on measuring virtual reality, hip arthroplasty, surgical skills, medical students

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: a. undergraduate medical students at Aristotle University of Thessaloniki Exclusion criteria: postgraduate medical students prior experience in THA or general surgery.

Sites / Locations

  • Aristotle University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control Group

VR Group

Arm Description

This group will include medical students who will only watch instructional videos on basic THA skills on the cup and stem implantation before actual implantation on sawbones

This group will include medical students who will watch instructional videos and perform three consecutive VR sessions on basic THA skills on the cup and stem implantation before actual implantation on sawbones

Outcomes

Primary Outcome Measures

Medical students surgical skills differences between VR and control group.
The primary outcome will be the mean difference between the asked predefined and the actual implanted cup inclination or cup version between the control and VR groups.

Secondary Outcome Measures

Surgical skills differences between cup and stem implantation for each medical student (the one implantation will be performed following VR training and the other not)
The secondary outcome will be the percentage difference of the target approach between the asked and the actual implanted cup inclination or cup version for each participant performing implantation. Differences in completing the task between groups will also be recorded ( time needed to complete the task and asking for assistance).

Full Information

First Posted
March 29, 2023
Last Updated
March 29, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT05807828
Brief Title
VR Simulation and Basic Skills in THA
Acronym
MD-VR-THA
Official Title
The Role of Virtual Reality Simulation in Acquiring Basic Surgical Skills in Total Hip Arthroplasty by Medical Students- a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective randomised clinical trial aims to test if virtual reality (VR) simulation helps acquire basic surgical skills in total hip arthroplasty (THA) by medical students. The main question[s] it aims to answer are: Can VR simulation develop the medical students' basic surgical skills and medical knowledge in THA? Will VR simulation become a part of orthopaedic surgical education? Participants will be randomised into two groups (VR and control). They will be asked to watch a very detailed video explaining basic rules and skills in implanting the acetabular cup and femoral stem in THA The VR group will perform at least three VR THA sessions concerning cup (inclination) and stem (version) implantation Then all participants will be asked to implant a cup and a stem in a predefined inclination and version, respectively, in sawbones The mean difference between the predefined and the actual implanted cup inclination and version of the stem will be compared between groups
Detailed Description
This study is a prospective randomized controlled trial and received approval from the A.U.Th. Institutional Review Board. Eligible study participants include undergraduate medical students at our university. Exclusion criteria include a. postgraduate medical students b. prior experience in THA or general surgery. One week before the planned VR-THA surgery session, all eligible A.U.Th. Medical students will be invited to an information session regarding the study and will be voluntarily enrolled, providing inform consent. Medical students were explicitly chosen for participation because they are surgically naïve and would most likely benefit from basic skills training in THA. Immediately after enrollment, medical students will be asked to complete a multiple-choice pretest to quantify their baseline medical and procedural knowledge of hip arthritis and THA. All participants will be unaware and unable to prepare for the pretest assessment, which allows the test scores to be considered an accurate measure of baseline knowledge. The medical students will be asked to watch a detailed video explaining basic rules and skills for implanting the acetabular cup and femoral stem in THA. The video will be focused on practices and methods to achieve specific cup inclination and stem version during implantation. All participants will be randomized to the VR simulation or control group for cup inclination assessment by a computerized random number generator. Participants will be privately notified of their randomization by e-mail and asked not to disclose their designated cohort with any other study participant or research personnel. Only a research team member will be aware of the cohort assignments during this study. The participants enrolled on the VR group for cup inclination will be the control group for the stem version group and vice versa. Before the VR-THA, participants will be asked to complete a survey evaluating their previous video games and VR technology experience. All control group participants will then be asked to implant a cup or a stem in a predefined inclination and version in sawbones. The cup inclination and stem version will be evaluated using specific goniometers and assessment of photographs taken during implantation. The evaluation will be performed by study personnel unaware of the participants' group assignment. All VR group participants will then be asked to complete three consecutive VR sessions using the VR system (ORama VR, Geneva, Switzerland), performing cup or stem implantation based on their group. All VR group participants will then be asked to implant a cup or a stem in a predefined inclination and version in sawbones. The cup inclination and stem version will be evaluated using the same specific goniometers and assessment of photographs that will be taken during implantation. The evaluation will be performed by the same study personnel unaware of the participants' group assignment. This personnel will also record the time needed for implantation. During implantation in sawbones, a study assistant will be present who will be instructed to intervene only if the study participants request assistance or cannot progress through the task. Upon completion of the VR-THAs, participants will complete a survey focused on their interest in using VR simulations for surgical skills training and assessing for potential negative consequences. Power analysis was performed, indicating that more than 30 participants will be necessarily enrolled in each group. The primary outcome will be the mean difference between the asked predefined and the actual implanted cup inclination or cup version between the control and VR groups. The secondary outcomes will be the percentage difference of the target approach between the asked and the actual implanted cup inclination or cup version for each participant performing implantation (one task will be performed as the VR and the other as the control group). Differences in completing the task between groups will also be recorded ( time needed to complete the task and asking for assistance). Two weeks later, all participants will perform the implantation on sawbones once again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Educational Problems, Hip Arthroplasty, Osteoarthritis, Hip, Medical Students
Keywords
virtual reality, hip arthroplasty, surgical skills, medical students

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will be randomized to the VR simulation or control group for cup inclination and stem version assessment by a computerized random number generator. The VR group will perform implantation on sawbones after VR education and the control group without VR education.
Masking
Outcomes Assessor
Masking Description
The personnel that will assess the cup inclination and stem version will not know the group assignment of the participants
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
This group will include medical students who will only watch instructional videos on basic THA skills on the cup and stem implantation before actual implantation on sawbones
Arm Title
VR Group
Arm Type
Other
Arm Description
This group will include medical students who will watch instructional videos and perform three consecutive VR sessions on basic THA skills on the cup and stem implantation before actual implantation on sawbones
Intervention Type
Procedure
Intervention Name(s)
VR simulation on basic THA skills
Intervention Description
The medical students' VR group will perform three VR simulation sessions on basic THA skills on the cup and stem implantation before actual implantation.
Primary Outcome Measure Information:
Title
Medical students surgical skills differences between VR and control group.
Description
The primary outcome will be the mean difference between the asked predefined and the actual implanted cup inclination or cup version between the control and VR groups.
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Surgical skills differences between cup and stem implantation for each medical student (the one implantation will be performed following VR training and the other not)
Description
The secondary outcome will be the percentage difference of the target approach between the asked and the actual implanted cup inclination or cup version for each participant performing implantation. Differences in completing the task between groups will also be recorded ( time needed to complete the task and asking for assistance).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: a. undergraduate medical students at Aristotle University of Thessaloniki Exclusion criteria: postgraduate medical students prior experience in THA or general surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eustathios Kenanidis, Ass.Prof.
Phone
6973693693
Ext
+030
Email
ekenanidis@auth.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Panagiotis Boutos, Med. Stud.
Phone
6947895512
Ext
+030
Email
pgmpoutos@auth.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleftherios Tsiridis, Professor
Organizational Affiliation
Aristotle University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aristotle University Medical School
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eustathios Kenanidis, Ass. Prof.
Phone
6973693693
Ext
+030
Email
ekenanidis@auth.gr
First Name & Middle Initial & Last Name & Degree
Panagiotis Boutos, Med. Stud.
Phone
6947895512
Ext
+030
Email
pgboutos@auth.gr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available to other researchers upon publication
IPD Sharing Time Frame
Upon publication and forever
IPD Sharing Access Criteria
Upon publication and forever
Citations:
PubMed Identifier
31786991
Citation
Logishetty K, Rudran B, Cobb JP. Virtual reality training improves trainee performance in total hip arthroplasty: a randomized controlled trial. Bone Joint J. 2019 Dec;101-B(12):1585-1592. doi: 10.1302/0301-620X.101B12.BJJ-2019-0643.R1.
Results Reference
background
PubMed Identifier
31056442
Citation
Hooper J, Tsiridis E, Feng JE, Schwarzkopf R, Waren D, Long WJ, Poultsides L, Macaulay W; NYU Virtual Reality Consortium. Virtual Reality Simulation Facilitates Resident Training in Total Hip Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Oct;34(10):2278-2283. doi: 10.1016/j.arth.2019.04.002. Epub 2019 Apr 8.
Results Reference
result
PubMed Identifier
31929324
Citation
Logishetty K, Gofton WT, Rudran B, Beaule PE, Cobb JP. Fully Immersive Virtual Reality for Total Hip Arthroplasty: Objective Measurement of Skills and Transfer of Visuospatial Performance After a Competency-Based Simulation Curriculum. J Bone Joint Surg Am. 2020 Mar 18;102(6):e27. doi: 10.2106/JBJS.19.00629.
Results Reference
result

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VR Simulation and Basic Skills in THA

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