Educational ProblemsMD-VR-THANCT05807828
VR Simulation and Basic Skills in THA
A study testing VR simulation on basic THA skills in people with Educational Problems and Hip Arthroplasty, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Hip Arthroplasty, Osteoarthritis, Hip
- What is being tested?
- VR simulation on basic THA skills
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGreece
- Study dates
- 26 Mar 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- undergraduate medical students at Aristotle University of Thessaloniki
Who cannot join
- postgraduate medical students
- prior experience in THA or general surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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
Read the 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).
- Being tested
- VR simulation on basic THA skills
- Keywords
- virtual reality, hip arthroplasty, surgical skills, medical students
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR simulation on basic THA skillsProcedure or surgery
The medical students' VR group will perform three VR simulation sessions on basic THA skills on the cup or stem implantation before actual implantation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: VR simulation on basic THA skills |
| 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 Receives: Procedure: VR simulation on basic THA skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Months
Secondary outcomes (2)
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.
Measured: 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.
Measured: seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start26 Mar 2023
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- ORamaVr SA ( Switzerland)
- Responsible party
- Principal investigator, Eustathios Kenanidis, Aristotle University Of Thessaloniki
- Investigators
- Eleftherios Tsiridis, Professor, Principal investigator, Aristotle University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807828
- Sponsor's protocol ID
- 79/2023
- Acronym
- MD-VR-THA
- Status last verified
- May 2025
- First submitted
- 29 Mar 2023
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available to other researchers upon publication
Publications
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.
PubMed 31786991Hooper 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.
PubMed 31056442Logishetty 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.
PubMed 31929324Kenanidis 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.
PubMed 37993676
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05807828
- Acronym / sponsor ID
- MD-VR-THA / 79/2023
- Keywords
- virtual reality, hip arthroplasty, surgical skills, medical students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- ORamaVr SA ( Switzerland)
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Procedure: VR simulation on basic THA skillsThis 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 | Procedure: VR simulation on basic THA skillsThis 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- undergraduate medical students at Aristotle University of Thessaloniki
Key exclusion criteria (2 listed)
- postgraduate medical students
- prior experience in THA or general surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR simulation on basic THA skillsThe medical students' VR group will perform three VR simulation sessions on basic THA skills on the cup or stem implantation before actual implantation. | Procedure or surgery | Control Group, VR Group |
Primary outcome
Medical Students Surgical Skills Differences Between VR and Control Group.
Time frame: 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.
2 secondary outcomes
Surgical Skills Differences in Implantation Following VR Training vs. No Training
Time frame: 2 months
Time Needed to Perform Each Task
Time frame: seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31786991Logishetty 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 publication: PubMed 31056442Hooper 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 publication: PubMed 31929324Logishetty 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.
- Derived from this study: PubMed 37993676Kenanidis 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.
- Individual participant dataSharing planned: Yes. The data will be available to other researchers upon publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleftherios Tsiridis, Professor principal investigator
Aristotle University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR simulation on basic THA skills in people with Educational Problems and Hip Arthroplasty, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Students Surgical Skills Differences Between VR and Control Group. (time frame: 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05807828, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.