VR Simulation and Basic Skills in THA

NCT05807828 | Completed Results

• 1 other identifier: 79/2023
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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. 1.Can VR simulation develop the medical students' basic surgical skills and medical knowledge in THA?
2. 2.Will VR simulation become a part of orthopaedic surgical education?
3. 3.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
4. 4.The VR group will perform at least three VR THA sessions concerning cup (inclination) and stem (version) implantation
5. 5.Then all participants will be asked to implant a cup and a stem in a predefined inclination and version, respectively, in sawbones
6. 6.The mean difference between the predefined and the actual implanted cup inclination and version of the stem will be compared between groups

Conditions

Educational Problems; Hip Arthroplasty; Osteoarthritis, Hip; Medical Students

Keywords

virtual reality; hip arthroplasty; surgical skills; medical students

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Surgical Skills Differences in Implantation Following VR Training vs. No Training

  2 months

• Time Needed to Perform Each Task

  seconds

Study Arms (2)

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

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

Procedure: VR simulation on basic THA skills

Interventions

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.

Control Group; VR Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a. undergraduate medical students at Aristotle University of Thessaloniki

You may not qualify if:

• postgraduate medical students
• prior experience in THA or general surgery.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• ORamaVr SA ( Switzerland): collaborator

Study Sites (1)

Aristotle University Medical School

Thessaloniki, Greece

Location

Related Publications (4)

• 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.

  PMID: 31786991 BACKGROUND

• 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.

  PMID: 31056442 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.

  PMID: 31929324 RESULT

• 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.

  PMID: 37993676 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Limitations 1. We used medical students and not junior resident surgeons which may be more appropriate for this study. Medical students are completely naïve to these procedures, more easily found and not subjected to surgical operations. This controlled environment will not be available during residency. 2. The Saw Bone model and the VR environment are not completely accurate representations of an actual surgical scenario.

Results Point of Contact

• Title: Eustathios Kenanidis - Assistant Professor of Orthopaedic Surgery & Traumatology
• Organization: 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

ekenanidis@auth.gr

6973693693

Study Officials

• Eleftherios Tsiridis, Professor

  Aristotle University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The personnel that will assess the cup inclination and stem version will not know the group assignment of the participants
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery & Traumatology

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: March 26, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon publication and forever
• Access Criteria: Upon publication and forever

Locations

GR (1)