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NCT Number: NCT06612619

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Academy for Medical Education and Simulation

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Amanuds Gustafsson, MD, PhD

CONTACT

[email protected]

4526792011

Mads E Jacobsen, MD

CONTACT

[email protected]

Mikkel ES Nielsen, Medical Student

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PGY 1 and 2 doctors working in an orthopeadic department

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

Treatment and study plan

Dyad instruction

Behavioral

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

Primary outcomes

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

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

    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

Secondary outcomes

  1. Hands-on training time

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

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

  2. Test score of each iteration of training

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

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

  3. Failure to achieve mastery standard

    Time frame: Up to 4 months from enrollment

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

  4. Calendar time to mastery

    Time frame: Up to 4 months from enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amandus Gustafsson, MD, PhD

CONTACT

[email protected]

4526792011

Mads E Jacobsen, MD

CONTACT

[email protected]

4560777357

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Official study title

Dyad Versus Single Instruction for Simulation-based Training in Proximal Femoral Fracture Osteosynthesis: a Non-inferiority Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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