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| Name | Class |
|---|---|
| ORamaVr SA ( Switzerland) | UNKNOWN |
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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:
Participants will be randomised into two groups (VR and control).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | This group will include medical students who will only watch instructional videos on basic THA skills on the cup or stem implantation before actual implantation on sawbones |
|
| VR Group | Other | This group will include medical students who will watch instructional videos and perform three consecutive VR sessions on basic THA skills on the cup or stem implantation before actual implantation on sawbones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR simulation on basic THA skills | Procedure | The medical students' VR group will perform three VR simulation sessions on basic THA skills on the cup or stem implantation before actual implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
a. undergraduate medical students at Aristotle University of Thessaloniki
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleftherios Tsiridis, Professor | Aristotle University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotle University Medical School | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31786991 | Background | 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. | |
| 31056442 | Result | 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. |
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The data will be available to other researchers upon publication
Upon publication and forever
Upon publication and forever
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees | 2 Months |
|
The study takes 2 months to complete. Our study is a non-intervention study performed by medical students in sawbones, so no adverse event is expected.
Our study did not include any intervention for the participants. All students simply watch training videos or conduct VR sessions and then test their knowledge on sawbones. Our study is a non-intervention study performed by medical students in sawbones, so no adverse event is expected. So it makes sense that there are no adverse effects at all in our study. There is no mortality or other adverse event risk. This is the reason that 0% of the students are risk of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eustathios Kenanidis - Assistant Professor of Orthopaedic Surgery & Traumatology | 1. Academic Orthopaedic Department, Aristotle University Medical School, General Hospital Papageorgiou 2. Centre of Orthopaedic and Regenerative Medicine (CORE), Center for Interdisciplinary Research and Innovation (CIRI)-AUTh | 6973693693 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2023 | Aug 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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The personnel that will assess the cup inclination and stem version will not know the group assignment of the participants
| 2 months |
| 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. | seconds |
| 31929324 | Result | 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. |
| 37993676 | Derived | Kenanidis E, Boutos P, Voulgaris G, Zgouridou A, Gkoura E, Gamie Z, Papagiannakis G, Tsiridis E. Effectiveness of virtual reality compared to video training on acetabular cup and femoral stem implantation accuracy in total hip arthroplasty among medical students: a randomised controlled trial. Int Orthop. 2024 Mar;48(3):625-633. doi: 10.1007/s00264-023-06038-8. Epub 2023 Nov 23. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years of medical school attended | Medical students were asked to complete a multiple-choice pretest determining their school age. | Count of Participants | Participants |
|
| Previous VR technology experience | Number | participants |
|
| Medical and procedural knowledge of hip arthritis and THA | Number | participants |
|
| 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. |
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | 2 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | seconds |
|
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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. | 0 | 47 | 0 | 47 | 0 | 47 |
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| ekenanidis@auth.gr |
| D012216 |
| Rheumatic Diseases |
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). |
| paired t-test |
| <0.05 |
| Mean Difference (Final Values) |
| 89.8 |
| Standard Deviation |
| 133.9 |
| 2-Sided |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| <0.05 |
| Median Difference (Final Values) |
| 2 |
| 2-Sided |
| Superiority |