VR Simulation and Basic Skills in THA

Not Applicable

Completed

Conditions: Hip Arthroplasty
Educational Problems
Osteoarthritis, Hip
Medical Students

Registration Number: NCT05807828

Lead Sponsor: Aristotle University Of Thessaloniki

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medical Students Surgical Skills Differences Between VR and Control Group.	2 Months	The primary outcome will be the mean difference between the asked predefined and the actual implanted cup and stem inclination or version between the Control and VR groups. After completing VR training, all participants were asked to implant the cup at a 60-degree inclination in sawbones and the femoral stem at 20 degrees of anteversion. The cup inclination and stem version were evaluated using goniometers and performed by study personnel unaware of the participant's group assignment. To determine the cup inclination and femoral stem version angles, we utilised a hemipelvis and a femoral sawbone, clamps, an acetabular cup and a femoral rasp with an insertion handle, and a standard goniometer. So, the primary outcome was the mean difference between the asked predefined (60 degrees cup inclination/ 20 degrees stem anteversion) and the actual implanted cup and stem inclination or version by the students on sawbones between the Control and VR groups.

Secondary Outcome Measures

Name	Time	Method
Surgical Skills Differences in Implantation Following VR Training vs. No Training	2 months	This secondary outcome will assess the difference between the target and actual implantations performed by students with or without VR training. Each medical student performed two implantations, one with and the other without VR training. The implantation with VR training was assessed in the VR group and the other in the control group. All implantations following VR training were included in the VR group, and those without VR training were included in the Control group. For this measurement, the cup or stem implantation was not evaluated. Each group included both stem and cup implantations, based on whether VR was used or not for the implantation. We had just one value for each arm, rather than multiple assessments. We will report deviations from the predefined target of implantation, presenting the data individually in degrees of deviation.
Time Needed to Perform Each Task	seconds	Time needed for implantation from each participant was recorded both for stem and cup. Each participant performed one implantation following a previous VR training and another without training. Both times were recorded.