Learning Curves and Outcomes of Simulation-based TrainingNCT06612619
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
A study testing Dyad instruction in people with Learning Curves and Outcomes of Simulation-based Training, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Learning Curves and Outcomes of Simulation-based Training
- What is being tested?
- Dyad instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Oct 2024to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PGY 1 and 2 doctors working in an orthopeadic department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen Academy for Medical Education and Simulation
Copenhagen, 2100
Amanuds Gustafsson, MD, PhD, 4526792011, amandus.gustafsson.02@regionh.dk
Mads E Jacobsen, MD, mads.emil.jacobsen@regionh.dk
About this study
Official title: Dyad Versus Single Instruction for Simulation-based Training in Proximal Femoral Fracture Osteosynthesis: a Non-inferiority Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Dyad instruction
- Keywords
- Simulation-based training, Mastery standards, Proximal femoral fracture, Medical Education, Osteosynthesis, Orthopeadic surgery, Dyad instruction
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyad instructionBehavioural
Rather than being instructed solo or one-on-one the trainees are instructed in pairs of two (dyad).
| Study group | Role | What they receive |
|---|---|---|
| One-on-one instruction to simulation-based training | No intervention | The usual instruction with one instructor instructing the trainee in simulation-based training in osteosynthesis of proximal femoral fractures |
| Dyad instruction | Active comparator | 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. Receives: Behavioral: Dyad instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment until mastery is achieved, or up to 4 months
Secondary outcomes (4)
Hands-on training time
The hands-on time the trainee is actively training on the simulator
Measured: From enrollment until mastery is achieved, or up to 4 months
Test score of each iteration of training
Test scores for each iteration of training until the trainee achieves the mastery standard
Measured: From enrollment until mastery is achieved, or up to 4 months
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).
Measured: Up to 4 months from enrollment
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.
Measured: Up to 4 months from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start9 Oct 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning Curves and Outcomes of Simulation-based TrainingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amandus Gustafsson, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612619
- Sponsor's protocol ID
- F-24056399
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will only share IPD based on a specific request or by demand of a journal
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyad Versus Single Instruction for Simulation-based Training in Proximal Femoral Fracture Osteosynthesis: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06612619
- Acronym / sponsor ID
- F-24056399
- Keywords
- Simulation-based training, Mastery standards, Proximal femoral fracture, Medical Education, Osteosynthesis, Orthopeadic surgery, Dyad instruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-on-one instruction to simulation-based training | No intervention | –The usual instruction with one instructor instructing the trainee in simulation-based training in osteosynthesis of proximal femoral fractures |
| Dyad instruction | Active comparator | Behavioral: Dyad instructionDyad 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PGY 1 and 2 doctors working in an orthopeadic department
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Dyad instructionRather than being instructed solo or one-on-one the trainees are instructed in pairs of two (dyad). | Behavioural | Dyad instruction |
Primary outcome
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
4 secondary outcomes
Hands-on training time
Time frame: From enrollment until mastery is achieved, or up to 4 months
Test score of each iteration of training
Time frame: From enrollment until mastery is achieved, or up to 4 months
Failure to achieve mastery standard
Time frame: Up to 4 months from enrollment
Calendar time to mastery
Time frame: Up to 4 months from enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided. We will only share IPD based on a specific request or by demand of a journal
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyad instruction in people with Learning Curves and Outcomes of Simulation-based Training, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandus Gustafsson, MD, PhD (4526792011, amandus.gustafsson.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of two-hour self-trainin sessions to achieve mastery standard (time frame: From enrollment until mastery is achieved, or up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.