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Simulation-based Arthroscopic Surgery Study

Simulation-based Arthroscopic Surgery Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02777333
Enrollment
30
Registered
2016-05-19
Start date
2016-01-31
Completion date
2017-07-31
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroscopy Training

Keywords

Simulation, Arthroscopy, Motion analysis

Brief summary

The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).

Detailed description

This single blinded randomised controlled study of junior orthopaedic trainees aims to assess whether the addition of simulation training improves arthroscopic technical skills performance of junior orthopaedic trainees during knee arthroscopy in the operating theatre compared to their usual clinical training programme. This will be assessed using objective motion analysis parameters recorded from wireless elbow-mounted motion sensors during surgery.

Interventions

BEHAVIORALSimulation training

Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study. * Healthy adults, Male or Female, aged 18 years or above. * Enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts

Exclusion criteria

* Unwilling or unable to provide informed consent * Previously completed higher surgical training programme

Design outcomes

Primary

MeasureTime frameDescription
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

Secondary

MeasureTime frameDescription
Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the time taken by participants to perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of movements (below the threshold for 'hand movements' above in outcome 1, but above the data noise threshold) taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.
Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where each hand is stationary while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where both hands are stationary at the same time while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will be analysed for the relative activity and dominance of each hand during the procedure while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre3 monthsValidated global rating scale for assessing diagnostic knee arthroscopy performance
Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsWireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms to calculate the smoothness (also known as 'jerk', the first derivative of acceleration by time, or third derivative of distance by time) of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol according to a standardised protocol.
Motion Analysis Parameters During Simulation3 monthsChange in participant performance on dry, bench top box trainers and anatomical simulators between baseline and 3 months using motion analysis parameters described in Primary outcome 1 and secondary outcomes 2-8 as measured by wireless elbow-mounted accelerometer and gyroscopic sensors
Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)3 monthsUse of MELODIC (Multivariate Exploratory Linear Optimized Decomposition into Independent Components) to identify resting state networks, and analyse differences in functional connectivity at baseline and three months between the intervention and control arms.
Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)3 monthsUsing FSLVBM (fMRIB's Software Library Voxel Based Morphometry) to calculate voxel-wise changes in grey matter volumes at baseline and three months between the intervention and control arms. Changes in VBM imply changes in grey matter volume and represent structural brain change.
Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)3 monthsUsing FDT (fMRIB's Diffusion Toolbox) to model local diffusion and changes in tractography at baseline and three months between the intervention and control arms. Changes in diffusion imply micro-structural (axonal) connectivity and represent structural brain change.
Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)3 monthsQuantitative magnetisation transfer imaging estimates liquid and semisolid (macromolecular) constituents of tissue at baseline and three months between the intervention and control arms. Changes in macromolecular content imply micro-structural (myelin) connectivity and represent structural brain change.
Feasibility of Additional Simulation Training3 monthsQualitative survey of participants opinions of the addition of simulation to their usual clinical training programme
Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre3 monthsPreviously described motion parameters of participants performing a diagnostic knee arthroscopy in theatre (see Primary outcome 1, and secondary outcomes 2-8) reported as a ratio to the 'ideal' performance as measured from the supervising clinician performing an optimal diagnostic knee arthroscopy on the same patient as the participant while wearing the wireless elbow-mounted accelerometer and gyroscopic sensors which will record 6 degree of freedom motion data to allow calculation of 'number of hand movements', 'smoothness', 'time taken', 'minor hand movements', 'stationary time', 'idle time' and dominance'

Countries

United Kingdom

Participant flow

Recruitment details

SHO trainees (PGY 2-3 equivalent) within nationally approved T&O training rotations at an English teaching hospital were eligible for inclusion. Exclusions; more than 2 years of surgical training; previous admission to a higher surgical training program; performed or assisted in over 10 arthroscopic or minimal-access procedures.

Participants by arm

ArmCount
Simulation Training
Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
15
Non-simulation/Routine Training
Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicSimulation TrainingNon-simulation/Routine TrainingTotal
Age, Continuous26.02 years26.34 years26.18 years
Postgraduate year
PGY2
12 Participants12 Participants24 Participants
Postgraduate year
PGY3
3 Participants3 Participants6 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
8 Participants6 Participants14 Participants
Sex: Female, Male
Male
7 Participants9 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

Primary

Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Simulation TrainingNumber of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre544 hand movements
Non-simulation/Routine TrainingNumber of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre893 hand movements
Secondary

Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Previously described motion parameters of participants performing a diagnostic knee arthroscopy in theatre (see Primary outcome 1, and secondary outcomes 2-8) reported as a ratio to the 'ideal' performance as measured from the supervising clinician performing an optimal diagnostic knee arthroscopy on the same patient as the participant while wearing the wireless elbow-mounted accelerometer and gyroscopic sensors which will record 6 degree of freedom motion data to allow calculation of 'number of hand movements', 'smoothness', 'time taken', 'minor hand movements', 'stationary time', 'idle time' and dominance'

Time frame: 3 months

ArmMeasureGroupValue (MEDIAN)
Simulation TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Time taken2.1 Performance ratio (Participant:superviso
Simulation TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Minor hand movements3.8 Performance ratio (Participant:superviso
Simulation TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Smoothness1.2 Performance ratio (Participant:superviso
Simulation TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Hand movements1.9 Performance ratio (Participant:superviso
Non-simulation/Routine TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Hand movements3.3 Performance ratio (Participant:superviso
Non-simulation/Routine TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Minor hand movements10.3 Performance ratio (Participant:superviso
Non-simulation/Routine TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Smoothness2.6 Performance ratio (Participant:superviso
Non-simulation/Routine TrainingDeviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in TheatreRatio of Time taken4.3 Performance ratio (Participant:superviso
Secondary

Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)

Using FDT (fMRIB's Diffusion Toolbox) to model local diffusion and changes in tractography at baseline and three months between the intervention and control arms. Changes in diffusion imply micro-structural (axonal) connectivity and represent structural brain change.

Time frame: 3 months

Secondary

Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will be analysed for the relative activity and dominance of each hand during the procedure while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

Time frame: 3 months

Secondary

Feasibility of Additional Simulation Training

Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme

Time frame: 3 months

Population: Data were not collected

Secondary

Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre

Validated global rating scale for assessing diagnostic knee arthroscopy performance

Time frame: 3 months

Population: Data were not collected

Secondary

Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where both hands are stationary at the same time while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

Time frame: 3 months

Population: Data were not collected

Secondary

Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of movements (below the threshold for 'hand movements' above in outcome 1, but above the data noise threshold) taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Simulation TrainingMinor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre176 minor hand movements
Non-simulation/Routine TrainingMinor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre435 minor hand movements
Secondary

Motion Analysis Parameters During Simulation

Change in participant performance on dry, bench top box trainers and anatomical simulators between baseline and 3 months using motion analysis parameters described in Primary outcome 1 and secondary outcomes 2-8 as measured by wireless elbow-mounted accelerometer and gyroscopic sensors

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Simulation TrainingMotion Analysis Parameters During Simulation131 Hand movements
Non-simulation/Routine TrainingMotion Analysis Parameters During Simulation249 Hand movements
Secondary

Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)

Quantitative magnetisation transfer imaging estimates liquid and semisolid (macromolecular) constituents of tissue at baseline and three months between the intervention and control arms. Changes in macromolecular content imply micro-structural (myelin) connectivity and represent structural brain change.

Time frame: 3 months

Secondary

Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)

Use of MELODIC (Multivariate Exploratory Linear Optimized Decomposition into Independent Components) to identify resting state networks, and analyse differences in functional connectivity at baseline and three months between the intervention and control arms.

Time frame: 3 months

Secondary

Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms to calculate the smoothness (also known as 'jerk', the first derivative of acceleration by time, or third derivative of distance by time) of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol according to a standardised protocol.

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Simulation TrainingSmoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre25,842 ms^-3
Non-simulation/Routine TrainingSmoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre36,846 ms^-3
Secondary

Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where each hand is stationary while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

Time frame: 3 months

Population: Data were not collected

Secondary

Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the time taken by participants to perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Simulation TrainingTime Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre320 seconds
Non-simulation/Routine TrainingTime Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre573 seconds
Secondary

Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)

Using FSLVBM (fMRIB's Software Library Voxel Based Morphometry) to calculate voxel-wise changes in grey matter volumes at baseline and three months between the intervention and control arms. Changes in VBM imply changes in grey matter volume and represent structural brain change.

Time frame: 3 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026