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RecruitingNCT06612619Updated Feb 11, 2026

Is Two-on-one Instruction in Virtual Reality Simulation-based Training of Operating Fractures of the Hip for Medical Students as Effective as One-on-one Instruction

An interventional study of Dyad instruction in Learning Curves and Outcomes of Simulation-based Training, sponsored by Copenhagen Academy for Medical Education and Simulation. Recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Copenhagen Academy for Medical Education and Simulation · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Sex
All
01

Study summary

The training of orthopedic surgeons has historically relied heavily on an apprenticeship model as the primary way of teaching the various procedures an aspiring surgeon needs to master. However, due to work-hour restrictions, demand for operating room efficiency, lack of supervisors and a growing focus and concern for patient safety, this model is challenged. As the importance of proper education and supervision of surgeons in training is still monumental, simulation-based training (SBT) has gained popularity within most medical specialties, as it provides a safe, and realistic room for training, where surgeons can effectively enhance their operating technique without posing a threat to patient safety. Techniques within orthopedic surgery are no exception to this tendency, and several virtual reality simulators and SBT courses has been developed. This includes the well-established SBT course in proximal femoral fracture (PFF) osteosynthesis, where evidence supported mastery standards for antegrade nailing, dynamic hip screw, Hansson pins and canulated screws have been established. A course that is recommended in the national curriculum for Danish orthopedic surgeons in training.

This change into a more technology- and simulation-based training does however pose challenges, that needs to be acknowledged and addressed to ensure the quality of the education and clinical skills of the orthopedic surgeons.

A key challenge is the limited resource of qualified instructors. These instructors are mainly experienced surgeons with a demanding and busy schedule, who teach part time in addition to their clinical work. It has previously been shown that teaching skills are to be taught by doctors and that good clinicians are not automatically good educators. With the burden of a busy clinical schedule, these experienced surgeons have difficulties finding the time to learn teaching skills.

It can therefore be challenging to educate enough qualified instructors. This poses a rising concern as the field of SBT is only expected to grow, with more courses in continuous development. Thus, potentially limiting the accessibility to orthopedic SBT courses, including the PFF course.

A possible solution for this challenge is dyad introductions. By converting one-on-one introduction to SBT for trainees into one-on-two introduction, it is possible to double the number of participants getting introductions without increasing the teaching load or expenses. This could significantly reduce the needed faculty time per trainee. Several studies have shown beneficial learning outcomes of dyad training. However, it seems, that the positive effects of dyad training cannot be translated into all types of medical simulations, and some studies suggests that the complexity and nature of the simulation defines whether dyad training is beneficial . It is theorized, that the effect of dyad training is caused by the learning of motor skills through mirror neurons during observation, and the distribution of knowledge during complex simulations according to the cognitive load theory. This suggests, that dyad training may be most beneficial in complex simulations requiring high levels of motor skills such as complex surgical procedures.

To our knowledge, no studies exist that examines whether dyad introduction can be equally used in the simulations of orthopedic procedures in general or PFF surgery specifically.

The aim of this study was to examine whether dyad introduction is non-inferior to the current one-on- one student introduction.

02

Conditions studied

  • Learning Curves and Outcomes of Simulation-based Training

Keywords

  • Simulation-based training
  • Mastery standards
  • Proximal femoral fracture
  • Medical Education
  • Osteosynthesis
  • Orthopeadic surgery
  • Dyad instruction
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • PGY 1 and 2 doctors working in an orthopeadic department

Exclusion criteria

Exclusion Criteria:

  • More than 10 osteosynthesis of proximal femoral fractures performed as the primary surgeon.
  • Failure to achieve mastery within the 4-month follow-up window.s
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • No intervention
    One-on-one instruction to simulation-based training

    The usual instruction with one instructor instructing the trainee in simulation-based training in osteosynthesis of proximal femoral fractures

  • Active comparator
    Dyad instruction

    Dyad or two-on-one instruction, where two trainees are instructed by an instructor at the same time and with the same time usage as in the non-intervention arm.

    Behavioral: Dyad instruction

Interventions

  • BehavioralDyad instruction

    Rather than being instructed solo or one-on-one the trainees are instructed in pairs of two (dyad).

05

What researchers measure

Primary outcomes

  1. Number of two-hour self-trainin sessions to achieve mastery standard

    The embeeded test in the simulator has established mastery standards. The primary outcome is how many two hour training sessions the trainees has to attend to achieve the mastery standard

    Time frame: From enrollment until mastery is achieved, or up to 4 months

Secondary outcomes

  1. Hands-on training time

    The hands-on time the trainee is actively training on the simulator

    Time frame: From enrollment until mastery is achieved, or up to 4 months

  2. Test score of each iteration of training

    Test scores for each iteration of training until the trainee achieves the mastery standard

    Time frame: From enrollment until mastery is achieved, or up to 4 months

  3. Failure to achieve mastery standard

    Number of participants who do not achieve the mastery standard within 9 training sessions or within 4 months of enrollment (whichever comes first).

    Time frame: Up to 4 months from enrollment

  4. Calendar time to mastery

    Time from enrollment to achievement of the mastery standard within the 4-month follow-up period. Participants not achieving mastery within the window will be classified accordingly.

    Time frame: Up to 4 months from enrollment.

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — We will only share IPD based on a specific request or by demand of a journal

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06612619
Lead sponsor
Copenhagen Academy for Medical Education and Simulation
Responsible party
Amandus Gustafsson (Associate Professor, MD, PhD, Copenhagen Academy for Medical Education and Simulation) — Principal investigator
First posted
Sep 25, 2024
Start date
Oct 9, 2024
Primary completion
Oct 15, 2026 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Feb 11, 2026

Study contacts

Amandus Gustafsson, MD, PhD
Contact
amandus.gustafsson.02@regionh.dk
4526792011
Mads E Jacobsen, MD
Contact
mads.emil.jacobsen@regionh.dk
4560777357

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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