Arthroscopy Training
Conditions
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
Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre | 3 months | Validated global rating scale for assessing diagnostic knee arthroscopy performance |
| Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 3 months | 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. |
| Motion Analysis Parameters During Simulation | 3 months | 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 |
| Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging) | 3 months | 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. |
| Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging) | 3 months | 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. |
| Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging) | 3 months | 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. |
| Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging) | 3 months | 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. |
| Feasibility of Additional Simulation Training | 3 months | Qualitative 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 Theatre | 3 months | 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' |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Simulation Training | Non-simulation/Routine Training | Total |
|---|---|---|---|
| Age, Continuous | 26.02 years | 26.34 years | 26.18 years |
| Postgraduate year PGY2 | 12 Participants | 12 Participants | 24 Participants |
| Postgraduate year PGY3 | 3 Participants | 3 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simulation Training | Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 544 hand movements |
| Non-simulation/Routine Training | Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 893 hand movements |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Simulation Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Time taken | 2.1 Performance ratio (Participant:superviso |
| Simulation Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Minor hand movements | 3.8 Performance ratio (Participant:superviso |
| Simulation Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Smoothness | 1.2 Performance ratio (Participant:superviso |
| Simulation Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Hand movements | 1.9 Performance ratio (Participant:superviso |
| Non-simulation/Routine Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Hand movements | 3.3 Performance ratio (Participant:superviso |
| Non-simulation/Routine Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Minor hand movements | 10.3 Performance ratio (Participant:superviso |
| Non-simulation/Routine Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Smoothness | 2.6 Performance ratio (Participant:superviso |
| Non-simulation/Routine Training | Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | Ratio of Time taken | 4.3 Performance ratio (Participant:superviso |
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
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
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
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
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simulation Training | Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 176 minor hand movements |
| Non-simulation/Routine Training | Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 435 minor hand movements |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simulation Training | Motion Analysis Parameters During Simulation | 131 Hand movements |
| Non-simulation/Routine Training | Motion Analysis Parameters During Simulation | 249 Hand movements |
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
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simulation Training | Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 25,842 ms^-3 |
| Non-simulation/Routine Training | Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 36,846 ms^-3 |
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simulation Training | Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 320 seconds |
| Non-simulation/Routine Training | Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre | 573 seconds |
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