NCT06729372

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 8, 2024

Last Update Submit

January 27, 2026

Conditions

Keywords

Deliberate flawed performanceHip fractureSimulation-based training

Outcome Measures

Primary Outcomes (1)

  • Retention test

    Performance on a validated test for the training

    7-10 days after training

Secondary Outcomes (2)

  • Post test

    Immediately after training

  • Transfer test

    7-10 days after training

Other Outcomes (1)

  • Pre-test

    Immediately before training

Study Arms (2)

Error avoidance training

ACTIVE COMPARATOR

Participants are instructed to avoid errors during simulation-based training

Behavioral: Error Avoidance Training

Deliberate flawed training

ACTIVE COMPARATOR

The participants are instructed to train deliberate errors during simulation-based training

Behavioral: Deliberate Flawed Performance

Interventions

Deliberate Flawed Performance during simulation-based training

Deliberate flawed training

Error Avoidance during simulation-based training

Error avoidance training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in medical school at University of Copenhagen passed exam in orthopaedic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Consultant, Ph.D., MD

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 11, 2024

Study Start

December 13, 2024

Primary Completion

May 26, 2025

Study Completion

May 26, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations