- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515092
Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents
Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents: A Crossover Randomized Controlled Trial
The goal of this study is to find out if virtual reality (VR) training helps orthopedic residents improve their skills in placing screws in the pelvic bone. The study will also compare VR training with standard training to see which method is more effective and easier to use.
The main questions it aims to answer are:
Does VR training improve performance compared to standard training? Does VR training help reduce procedure time and X-ray use? Do participants prefer VR training? Researchers will compare VR training with standard training using a crossover design, where all participants receive both types of training.
Participants will:
Take part in both VR and standard training sessions Practice the procedure on a bone model Be evaluated by experts on their performance Complete a satisfaction questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10300
- Faculty of medicine Vajira hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Orthopedic residents (PGY 1-4)
- Currently enrolled in the orthopedic training program at Vajira Hospital
Exclusion Criteria:
- Prior VR training in pelvic fixation procedures
- Experience performing antegrade anterior column screw placement more than 5 times
- Inability to complete all study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Simulation Training → Standard Training (Sequence AB)
Participants first undergo VR simulation training, followed by standard training after a washout period
|
Participants train using a VR platform simulating antegrade anterior column screw placement.
Three-dimensional pelvic models reconstructed from CT data are integrated into a virtual operating environment.
Participants interact using a VR headset with simulated instruments and fluoroscopic imaging, allowing repeated practice with real-time feedback.
Duration: up to 30 minutes.
Participants perform screw placement on a pelvic sawbone model under fluoroscopic guidance using standard instruments, including a 2.0 mm K-wire.
The setup simulates real operative conditions.
Duration: up to 30 minutes.
|
|
Active Comparator: Standard Training → VR Simulation Training (Sequence BA)
Participants first undergo standard training, followed by VR simulation training after a washout period.
|
Participants train using a VR platform simulating antegrade anterior column screw placement.
Three-dimensional pelvic models reconstructed from CT data are integrated into a virtual operating environment.
Participants interact using a VR headset with simulated instruments and fluoroscopic imaging, allowing repeated practice with real-time feedback.
Duration: up to 30 minutes.
Participants perform screw placement on a pelvic sawbone model under fluoroscopic guidance using standard instruments, including a 2.0 mm K-wire.
The setup simulates real operative conditions.
Duration: up to 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Rating Scale (GRS) Score for Technical Performance
Time Frame: Immediately after each training session
|
Overall technical performance score (range 6-36) assessed by two independent blinded orthopedic trauma experts using a validated Global Rating Scale.
A higher score means better outcomes.
|
Immediately after each training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure Time
Time Frame: Immediately after each training session
|
Total time required to complete the screw placement procedure (minutes).
|
Immediately after each training session
|
|
Fluoroscopy Time
Time Frame: Immediately after each training session
|
Total duration of fluoroscopic use during the procedure (seconds).
|
Immediately after each training session
|
|
Guidewire Reposition Attempts
Time Frame: Immediately after each training session
|
Number of times the guidewire trajectory is adjusted during the procedure.
|
Immediately after each training session
|
|
User Satisfaction (QUIS Score)
Time Frame: Immediately after each training session
|
Participant satisfaction assessed using the Questionnaire for User Interaction Satisfaction (Likert scale).
This score contains of 9-point bipolar Likert scale, the analysis focuses on Central Tendency (Mean) and Variability (Standard Deviation).
A Higher mean of the score indicates better outcome.
Minimum score =1, Maximum score = 9.
|
Immediately after each training session
|
Collaborators and Investigators
Investigators
- Study Chair: Pornsak Nirunsuk, Faculty of medicine Vajira hospital
Publications and helpful links
General Publications
- Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
- Kuhn AW, Yu JK, Gerull KM, Silverman RM, Aleem AW. Virtual Reality and Surgical Simulation Training for Orthopaedic Surgery Residents: A Qualitative Assessment of Trainee Perspectives. JB JS Open Access. 2024 Mar 20;9(1):e23.00142. doi: 10.2106/JBJS.OA.23.00142. eCollection 2024 Jan-Mar.
- McCloy R, Stone R. Science, medicine, and the future. Virtual reality in surgery. BMJ. 2001 Oct 20;323(7318):912-5. doi: 10.1136/bmj.323.7318.912. No abstract available.
- Gansslen A, Lindahl J, Lindtner RA, Krappinger D, Staresinic M. Special screw corridors and imaging in pelvic ring trauma. Arch Orthop Trauma Surg. 2025 Jan 4;145(1):110. doi: 10.1007/s00402-024-05610-0.
- Berk T, Zderic I, Schwarzenberg P, Pastor T, Drenchev L, Skulev HK, Richards G, Hierholzer C, Halvachizadeh S, Pape HC, Gueorguiev B. Antegrade anterior column acetabulum fracture fixation with cannulated compression headless screws-A biomechanical study on standardized osteoporotic artificial bone. PLoS One. 2024 Jun 3;19(6):e0300256. doi: 10.1371/journal.pone.0300256. eCollection 2024.
- Osterhoff G, Wulsten D, Babu S, Heyland M, Pari C. Antegrade versus retrograde screw fixation of anterior column acetabular fractures: a biomechanical in vitro study. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1307-1312. doi: 10.1007/s00068-019-01255-6. Epub 2019 Oct 29.
- Unal YC, Adanas C, Kaya S, Ozkan S, Ismailov U. Virtual reality headset versus traditional training in orthopedic surgery: A comparative study on real surgical performance in total knee arthroplasty. Medicine (Baltimore). 2024 Nov 22;103(47):e40615. doi: 10.1097/MD.0000000000040615.
- Martin KD, Akoh CC, Amendola A, Phisitkul P. Comparison of Three Virtual Reality Arthroscopic Simulators as Part of an Orthopedic Residency Educational Curriculum. Iowa Orthop J. 2016;36:20-5.
- Kayaalp ME, Konstantinou E, Karaismailoglu B, Lucidi GA, Kaymakoglu M, Vieider R, Giusto JD, Inoue J, Hirschmann MT. The metaverse in orthopaedics: Virtual, augmented and mixed reality for advancing surgical training, arthroscopy, arthroplasty and rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2025 Aug;33(8):3039-3050. doi: 10.1002/ksa.12723. Epub 2025 Jul 7.
- 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.
- de Andrade ALL, Yuamoto FY, Malcher CMSR, Appenzeller S, Garcia TA, Belangero WD. ARTHROSCOPY LEARNING IN VIRTUAL REALITY: SYSTEMATIC REVIEW AND METANALYSIS. Acta Ortop Bras. 2025 Aug 18;33(3):e287823. doi: 10.1590/1413-785220253303e287823. eCollection 2025.
- Cannon WD, Garrett WE Jr, Hunter RE, Sweeney HJ, Eckhoff DG, Nicandri GT, Hutchinson MR, Johnson DD, Bisson LJ, Bedi A, Hill JA, Koh JL, Reinig KD. Improving residency training in arthroscopic knee surgery with use of a virtual-reality simulator. A randomized blinded study. J Bone Joint Surg Am. 2014 Nov 5;96(21):1798-806. doi: 10.2106/JBJS.N.00058.
- Blumstein G, Zukotynski B, Cevallos N, Ishmael C, Zoller S, Burke Z, Clarkson S, Park H, Bernthal N, SooHoo NF. Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing. J Surg Educ. 2020 Jul-Aug;77(4):969-977. doi: 10.1016/j.jsurg.2020.01.002. Epub 2020 Feb 5.
- Vaughan N, Dubey VN, Wainwright TW, Middleton RG. A review of virtual reality based training simulators for orthopaedic surgery. Med Eng Phys. 2016 Feb;38(2):59-71. doi: 10.1016/j.medengphy.2015.11.021. Epub 2015 Dec 29.
- Hasan LK, Haratian A, Kim M, Bolia IK, Weber AE, Petrigliano FA. Virtual Reality in Orthopedic Surgery Training. Adv Med Educ Pract. 2021 Nov 10;12:1295-1301. doi: 10.2147/AMEP.S321885. eCollection 2021.
- Cevallos N, Zukotynski B, Greig D, Silva M, Thompson RM. The Utility of Virtual Reality in Orthopedic Surgical Training. J Surg Educ. 2022 Nov-Dec;79(6):1516-1525. doi: 10.1016/j.jsurg.2022.06.007. Epub 2022 Jul 9.
- Cate G, Barnes J, Cherney S, Stambough J, Bumpass D, Barnes CL, Dickinson KJ. Current status of virtual reality simulation education for orthopedic residents: the need for a change in focus. Global Surg Educ. 2023;2(1):46. doi: 10.1007/s44186-023-00120-w. Epub 2023 Mar 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- COA 248/2568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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