Clinical trial NCT05807828: VR Simulation and Basic Skills in 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
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Hip Arthroplasty
Osteoarthritis, Hip
Medical Students
Keywords: virtual reality
hip arthroplasty
surgical skills
medical students
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: ORamaVr SA ( Switzerland)
First posted: 2023-04-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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:

1. Can VR simulation develop the medical students' basic surgical skills and medical knowledge in THA?
2. Will VR simulation become a part of orthopaedic surgical education?

Participants will be randomised into two groups (VR and control).

1. 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
2. The VR group will perform at least three VR THA sessions concerning cup (inclination) and stem (version) implantation
3. Then all participants will be asked to implant a cup and a stem in a predefined inclination and version, respectively, in sawbones
4. 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

1. 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).
2. Differences in completing the task between groups will also be recorded ( time needed to complete the task and asking for assistance).

Eligibility criteria: Inclusion criteria:

a. undergraduate medical students at Aristotle University of Thessaloniki

Exclusion criteria:

1. postgraduate medical students
2. prior experience in THA or general surgery.

Primary outcomes:
measure: Medical Students Surgical Skills Differences Between VR and Control Group.
timeFrame: 2 Months
Secondary outcomes:
measure: Surgical Skills Differences in Implantation Following VR Training vs. No Training
timeFrame: 2 months
measure: Time Needed to Perform Each Task
timeFrame: seconds
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University Medical School
Study officials:
affiliation: Aristotle University Medical School
name: Eleftherios Tsiridis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.