Simulation Based Medical EducationNCT06729372
Optimizing Simulation-Based Training in Orthopedics: Exploring Deliberate Flawed Performance for Dynamic Hip Screw Osteosynthesis
A study testing Deliberate Flawed Performance and Error Avoidance Training in people with Simulation Based Medical Education, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial summary
Proximal femoral fractures (PFF) are associated with increased mortality when surgical intervention is delayed, with evidence supporting osteosynthesis within 12 to 24 hours of admission to minimize risk.1, 2 Consequently, surgical procedures for PFF should be mastered by orthopedic trainees early in their career. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Based Medical Education
- What is being tested?
- Deliberate Flawed Performance and Error Avoidance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Dec 2024to 26 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Enrolled in medical school at University of Copenhagen passed exam in orthopaedic surgery
Who cannot join
- prior clinical or simulation-based osteosynthesis experience inability to participate in the transfer and retention test within the designated timeframe after the completion of training
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Academy for Medical Education and Simulation
Copenhagen, 2100
About this study
Proximal femoral fractures (PFF) are associated with increased mortality when surgical intervention is delayed, with evidence supporting osteosynthesis within 12 to 24 hours of admission to minimize risk.1, 2 Consequently, surgical procedures for PFF should be mastered by orthopedic trainees early in their career. In Denmark, this necessity is reflected in the first-year specialist training curriculum, which designates PFF surgery as one of three procedures requiring mandatory competence assessment.3 From 2013 to 2019, orthopedic trainees performed 66% of all registered PFF surgeries in Denmark.4 However, evidence suggests that surgeries performed by surgeons in training can be associated with higher reoperation rates.2,5,6 Simulation-based training (SBT) has been proposed to reduce this risk, as it is associated with superior learning outcomes compared to other instructional modalities.7 In a Danish national needs assessment of SBT, osteosynthesis for PFF was ranked 2nd of 33 prioritized procedures within orthopedic surgery.8
Simulators for SBT of PFF osteosynthesis are available. One of them is the Swemac TraumaVision simulator and several studies have supplied both supporting validity evidence for the imbedded tests and evidence supported mastery standards for trainees to achieve before continued practice on patients in the operating room under supervision of senior colleagues.9-11 Accordingly, SBT is now part of the Danish national curriculum for specialist training in orthopaedic surgery.12
Read more
The training is based on directed self-regulated learning (DSRL), where trainees receive feedback after each iteration of training and use it to improve their performance in subsequent iterations. While DSRL appears to be noninferior to instructor-regulated training,13 experimental studies suggest a potential downside. Feedback given during training may improve immediate performance but can adversely affect long-term retention and the transfer of skills to new settings.14,15 Interestingly, evidence suggests that performing errors during early training may be essential to avoid them in the future16 possibly due to the to the reflection and cognitive activities that errors elicit in the learner.17-19 Further, exploratory behavior during training is shown to have a positive effect on performance outcomes.20 Indeed, evidence from outside the medical field indicates that error management training (EMT), training where errors are pursued and considered desirable for learning, slightly reduces performance during training compared to error avoidance training (EAT) but enhances post training and transfer performance with moderate effect sizes.21-23
Evidence within medical SBT remains limited. However, Dyre et al. have investigated the effect of EMT compared to EAT on medical students' SBT transabdominal fetal ultrasound scans. The students had the same training time, but those who trained with EMT had both statistically and clinically significantly better performance scores and diagnostic abilities on a transfer test on patients, with statistically large and moderate effect sizes, respectively.24 EMT traditionally comprises both an error component and an exploratory component. However, it has been shown that exposure to both correct and flawed performance demonstrations can enhance skill acquisition, provided that learners are informed what errors that the flawed performance contains. The correct example serves as a reference for performance standards, enabling learners to extract meaningful insights from the flawed performance.25,26 A proposed mechanism for this process is that encountering errors compels learners to actively engage with the material, forcing deeper cognitive processing and thereby enhancing training efficacy.27
Hence, there is a sizable knowledge gap as to how EMT may enhance SBT in surgery. It is not clear to what degree the error training component contributes to the perceived positive effects of EMT. Errors made in surgery can be detrimental to patient safety. Accordingly, it is meaningful to explore any method to reduce transfer of such mistakes from training to the clinical setting. Moreover, considering that trainees' time is a valuable and limited resource, and the setup of SBT comes at a cost, it is prudent to explore how these instructional methods may enhance the efficacy of SBT.
The aim of this study is to explore the effect of instructions in deliberate flawed performance (DFP) compared to EAT instructions on retention and transfer of skills on medical students when performing SBT of open surgery in form of osteosynthesis with dynamic hip screw (DHS).
- Conditions
- Simulation Based Medical Education
- Being tested
- Deliberate Flawed Performance, Error Avoidance Training
- Keywords
- Deliberate flawed performance, Hip fracture, Simulation-based training
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deliberate Flawed PerformanceBehavioural
Deliberate Flawed Performance during simulation-based training
Error Avoidance TrainingBehavioural
Error Avoidance during simulation-based training
| Study group | Role | What they receive |
|---|---|---|
| Error avoidance training | Active comparator | Participants are instructed to avoid errors during simulation-based training Receives: Behavioral: Error Avoidance Training |
| Deliberate flawed training | Active comparator | The participants are instructed to train deliberate errors during simulation-based training Receives: Behavioral: Deliberate Flawed Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention test
Performance on a validated test for the training
Measured: 7-10 days after training
Secondary outcomes (2)
Post test
Performance on a validated test of the training
Measured: Immediately after training
Transfer test
Performance on a validated test for a different, but similar training setup
Measured: 7-10 days after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start13 Dec 2024
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation Based Medical EducationStudies 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
- 70 participants (actual)
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
- NCT06729372
- Sponsor's protocol ID
- F-24069185
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Simulation-Based Training in Orthopedics: Exploring Deliberate Flawed Performance for Dynamic Hip Screw Osteosynthesis
- ClinicalTrials.gov ID
- NCT06729372
- Acronym / sponsor ID
- F-24069185
- Conditions
- Simulation Based Medical Education
- Keywords
- Deliberate flawed performance, Hip fracture, Simulation-based training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 11 Dec 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.
Proximal femoral fractures (PFF) are associated with increased mortality when surgical intervention is delayed, with evidence supporting osteosynthesis within 12 to 24 hours of admission to minimize risk.1, 2 Consequently, surgical procedures for PFF should be mastered by orthopedic trainees early in their career. In Denmark, this necessity is reflected in the first-year specialist training curriculum, which designates PFF surgery as one of three procedures requiring mandatory competence assessment.3 From 2013 to 2019, orthopedic trainees performed 66% of all registered PFF surgeries in Denmark.4 However, evidence suggests that surgeries performed by surgeons in training can be associated with higher reoperation rates.2,5,6 Simulation-based training (SBT) has been proposed to reduce this risk, as it is associated with superior learning outcomes compared to other instructional modalities.7 In a Danish national needs assessment of SBT, osteosynthesis for PFF was ranked 2nd of 33 prioritized procedures within orthopedic surgery.8
Simulators for SBT of PFF osteosynthesis are available. One of them is the Swemac TraumaVision simulator and several studies have supplied both supporting validity evidence for the imbedded tests and evidence supported mastery standards for trainees to achieve before continued practice on patients in the operating room under supervision of senior colleagues.9-11 Accordingly, SBT is now part of the Danish national curriculum for specialist training in orthopaedic surgery.12
The training is based on directed self-regulated learning (DSRL), where trainees receive feedback after each iteration of training and use it to improve their performance in subsequent iterations. While DSRL appears to be noninferior to instructor-regulated training,13 experimental studies suggest a potential downside. Feedback given during training may improve immediate performance but can adversely affect long-term retention and the transfer of skills to new settings.14,15 Interestingly, evidence suggests that performing errors during early training may be essential to avoid them in the future16 possibly due to the to the reflection and cognitive activities that errors elicit in the learner.17-19 Further, exploratory behavior during training is shown to have a positive effect on performance outcomes.20 Indeed, evidence from outside the medical field indicates that error management training (EMT), training where errors are pursued and considered desirable for learning, slightly reduces performance during training compared to error avoidance training (EAT) but enhances post training and transfer performance with moderate effect sizes.21-23
Evidence within medical SBT remains limited. However, Dyre et al. have investigated the effect of EMT compared to EAT on medical students' SBT transabdominal fetal ultrasound scans. The students had the same training time, but those who trained with EMT had both statistically and clinically significantly better performance scores and diagnostic abilities on a transfer test on patients, with statistically large and moderate effect sizes, respectively.24 EMT traditionally comprises both an error component and an exploratory component. However, it has been shown that exposure to both correct and flawed performance demonstrations can enhance skill acquisition, provided that learners are informed what errors that the flawed performance contains. The correct example serves as a reference for performance standards, enabling learners to extract meaningful insights from the flawed performance.25,26 A proposed mechanism for this process is that encountering errors compels learners to actively engage with the material, forcing deeper cognitive processing and thereby enhancing training efficacy.27
Hence, there is a sizable knowledge gap as to how EMT may enhance SBT in surgery. It is not clear to what degree the error training component contributes to the perceived positive effects of EMT. Errors made in surgery can be detrimental to patient safety. Accordingly, it is meaningful to explore any method to reduce transfer of such mistakes from training to the clinical setting. Moreover, considering that trainees' time is a valuable and limited resource, and the setup of SBT comes at a cost, it is prudent to explore how these instructional methods may enhance the efficacy of SBT.
The aim of this study is to explore the effect of instructions in deliberate flawed performance (DFP) compared to EAT instructions on retention and transfer of skills on medical students when performing SBT of open surgery in form of osteosynthesis with dynamic hip screw (DHS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Error avoidance training | Active comparator | Behavioral: Error Avoidance TrainingParticipants are instructed to avoid errors during simulation-based training |
| Deliberate flawed training | Active comparator | Behavioral: Deliberate Flawed PerformanceThe participants are instructed to train deliberate errors during simulation-based training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in medical school at University of Copenhagen passed exam in orthopaedic surgery
Key exclusion criteria (1 listed)
- prior clinical or simulation-based osteosynthesis experience inability to participate in the transfer and retention test within the designated timeframe after the completion of training
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 |
|---|---|---|
| Deliberate Flawed PerformanceDeliberate Flawed Performance during simulation-based training | Behavioural | Deliberate flawed training |
| Error Avoidance TrainingError Avoidance during simulation-based training | Behavioural | Error avoidance training |
Primary outcome
Retention test
Time frame: 7-10 days after training
Performance on a validated test for the training
2 secondary outcomes
Post test
Time frame: Immediately after training
Transfer test
Time frame: 7-10 days after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deliberate Flawed Performance and Error Avoidance Training in people with Simulation Based Medical Education, 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 1 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: finished, as of the sponsor's last update on 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention test (time frame: 7-10 days after training). 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 28 Jan 2026.