Educational Problems, Hip Arthroplasty, Medical Students, Osteoarthritis, Hip
Conditions
Keywords
virtual reality, hip arthroplasty, surgical skills, medical students
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).
Interventions
PROCEDUREVR simulation on basic THA skills
The medical students' VR group will perform three VR simulation sessions on basic THA skills on the cup or stem implantation before actual implantation.
Sponsors
ORamaVr SA ( Switzerland)
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The personnel that will assess the cup inclination and stem version will not know the group assignment of the participants
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group for Cup Training and VR Group for Stem Training This group include medical students who only watched instructional videos on basic THA skills on the cup implantation before actual implantation on sawbones. These students also watched instructional videos and performed three consecutive VR sessions on basic THA skills on the stem implantation before actual implantation on sawbones. | 54 |
| VR Group for Cup Training and Control Group for Stem Training This group include medical students who watched instructional videos and perform three consecutive VR sessions on basic THA skills on the cup implantation before actual implantation on sawbones. These students also watched only instructional videos on basic THA skills on the stem implantation before actual implantation on sawbones. | 47 |
| Total | 101 |
Baseline characteristics
| Characteristic | Control Group for Cup Training and VR Group for Stem Training | VR Group for Cup Training and Control Group for Stem Training | Total |
|---|---|---|---|
| Age, Continuous | 23.26 years STANDARD_DEVIATION 2.896 | 23.49 years STANDARD_DEVIATION 3.035 | 23.37 years STANDARD_DEVIATION 2.949 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 47 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medical and procedural knowledge of hip arthritis and THA Having knowledge of the fixation materials for hip arthroplasty | 11 participants | 11 participants | 22 participants |
| Medical and procedural knowledge of hip arthritis and THA Having knowledge of the pathophysiology of osteoarthritis | 42 participants | 38 participants | 80 participants |
| Medical and procedural knowledge of hip arthritis and THA Having knowledge of what a hip arthroplasty involves (femoral stem, femoral head, etc.) | 45 participants | 37 participants | 82 participants |
| Medical and procedural knowledge of hip arthritis and THA Previous attendance at orthopaedic surgery | 16 participants | 10 participants | 26 participants |
| Medical and procedural knowledge of hip arthritis and THA Previous education on a surgical procedure (not orthopaedic) | 15 participants | 10 participants | 25 participants |
| Previous VR technology experience Having general knowledge about vr technology | 53 participants | 47 participants | 100 participants |
| Previous VR technology experience Owning a vr headset | 2 participants | 0 participants | 2 participants |
| Previous VR technology experience Previous experience with vr headset | 28 participants | 16 participants | 44 participants |
| Previous VR technology experience Previous participation in a vr training programme | 7 participants | 3 participants | 10 participants |
| Region of Enrollment Greece | 54 Participants | 47 Participants | 101 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 32 Participants | 24 Participants | 56 Participants |
| Years of medical school attended 1 year of medical school attended | 2 Participants | 3 Participants | 5 Participants |
| Years of medical school attended 2 years of medical school attended | 5 Participants | 4 Participants | 9 Participants |
| Years of medical school attended 3 years of medical school attended | 7 Participants | 4 Participants | 11 Participants |
| Years of medical school attended 4 years of medical school attended | 12 Participants | 13 Participants | 25 Participants |
| Years of medical school attended 5 years of medical school attended | 24 Participants | 19 Participants | 43 Participants |
| Years of medical school attended 6 years of medical school attended | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 47 |
| other Total, other adverse events | 0 / 54 | 0 / 47 |
| serious Total, serious adverse events | 0 / 54 | 0 / 47 |
Outcome results
Primary
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 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.
Time frame: 2 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group for Cup Training and VR Group for Stem Training | Medical Students Surgical Skills Differences Between VR and Control Group. | Cup Implantation (mean) | 51.5 degrees | Standard Deviation 12.4 |
| Control Group for Cup Training and VR Group for Stem Training | Medical Students Surgical Skills Differences Between VR and Control Group. | Stem Implantation (mean) | 115.9 degrees | Standard Deviation 142.8 |
| VR Group for Cup Training and Control Group for Stem Training | Medical Students Surgical Skills Differences Between VR and Control Group. | Cup Implantation (mean) | 59.1 degrees | Standard Deviation 6.1 |
| VR Group for Cup Training and Control Group for Stem Training | Medical Students Surgical Skills Differences Between VR and Control Group. | Stem Implantation (mean) | 201.5 degrees | Standard Deviation 156.3 |
Comparison: The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.p-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Surgical Skills Differences in Implantation Following VR Training vs. No Training
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 frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group for Cup Training and VR Group for Stem Training | Surgical Skills Differences in Implantation Following VR Training vs. No Training | 54.5 degrees | Standard Deviation 106.6 |
| VR Group for Cup Training and Control Group for Stem Training | Surgical Skills Differences in Implantation Following VR Training vs. No Training | 89.8 degrees | Standard Deviation 133.9 |
Comparison: Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.p-value: <0.05paired t-test
Comparison: Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).p-value: <0.05paired t-test
Secondary
Time Needed to Perform Each Task
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.
Time frame: seconds
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group for Cup Training and VR Group for Stem Training | Time Needed to Perform Each Task | Time needed for cup implantation for Control cup and VR cup groups | 35 seconds | Standard Deviation 27 |
| Control Group for Cup Training and VR Group for Stem Training | Time Needed to Perform Each Task | Time needed for stem implantation for VR stem and Control stem groups | 43 seconds | Standard Deviation 46 |
| VR Group for Cup Training and Control Group for Stem Training | Time Needed to Perform Each Task | Time needed for cup implantation for Control cup and VR cup groups | 21 seconds | Standard Deviation 25 |
| VR Group for Cup Training and Control Group for Stem Training | Time Needed to Perform Each Task | Time needed for stem implantation for VR stem and Control stem groups | 45 seconds | Standard Deviation 37 |
Comparison: Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup groupp-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem groupp-value: <0.05Wilcoxon (Mann-Whitney)