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The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation training | Experimental | Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
|
| Non-simulation/Routine training | No Intervention | Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulation training | Behavioral | Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan L Rees, FRCS-Tr&Orth | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Orthopaedic Centre | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Non-simulation/Routine Training | Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | hand movements | 3 months |
|
12 weeks (study period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Some outcomes were not analysed as stated in the trial protocol as during the construct validation stage these were found to not correlate with performance
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr P Garfjeld Roberts | University of Oxford | 01865 227374 | patrick.garfjeldroberts@ndorms.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2015 | Nov 20, 2020 | Prot_SAP_000.pdf |
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| 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 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. | 3 months |
| Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre | Validated global rating scale for assessing diagnostic knee arthroscopy performance | 3 months |
| 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' | 3 months |
| 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 | 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| Feasibility of Additional Simulation Training | Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme | 3 months |
| Non-simulation/Routine Training |
Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Postgraduate year | Count of Participants | Participants |
|
| OG001 | Non-simulation/Routine Training | Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
|
|
| 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. | Posted | Median | Inter-Quartile Range | ms^-3 | 3 months |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | seconds | 3 months |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | minor hand movements | 3 months |
|
|
|
| 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. | Data were not collected | Posted | 3 months |
|
|
| 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. | Data were not collected | Posted | 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. | Not Posted | 3 months | Participants |
| Secondary | Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre | Validated global rating scale for assessing diagnostic knee arthroscopy performance | Data were not collected | Posted | 3 months |
|
|
| 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' | Posted | Median | Inter-Quartile Range | Performance ratio (Participant:superviso | 3 months |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | Hand movements | 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. | Not Posted | 3 months | Participants |
| 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. | Not Posted | 3 months | Participants |
| 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. | Not Posted | 3 months | Participants |
| 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. | Not Posted | 3 months | Participants |
| Secondary | Feasibility of Additional Simulation Training | Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme | Data were not collected | Posted | 3 months |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Non-simulation/Routine Training | Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme | 0 | 15 | 0 | 15 | 0 | 15 |
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| Ratio of Smoothness |
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| Ratio of Time taken |
|