Trial Outcomes & Findings for Simulation-based Arthroscopic Surgery Study (NCT NCT02777333)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

3 months

Results posted on

2021-06-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	Non-simulation/Routine Training Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Overall Study STARTED	15	15
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Non-simulation/Routine Training Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=15 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme	Total n=30 Participants Total of all reporting groups
Age, Continuous	26.02 years n=15 Participants	26.34 years n=15 Participants	26.18 years n=30 Participants
Sex: Female, Male Female	8 Participants n=15 Participants	6 Participants n=15 Participants	14 Participants n=30 Participants
Sex: Female, Male Male	7 Participants n=15 Participants	9 Participants n=15 Participants	16 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Postgraduate year PGY2	12 Participants n=15 Participants	12 Participants n=15 Participants	24 Participants n=30 Participants
Postgraduate year PGY3	3 Participants n=15 Participants	3 Participants n=15 Participants	6 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=13 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre	544 hand movements Interval 465.0 to 593.0	893 hand movements Interval 747.0 to 1242.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=13 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre	25,842 ms^-3	36,846 ms^-3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=13 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre	320 seconds Interval 294.0 to 392.0	573 seconds Interval 477.0 to 860.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=13 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre	176 minor hand movements Interval 133.0 to 209.0	435 minor hand movements Interval 310.0 to 652.0

SECONDARY outcome

Timeframe: 3 months

Population: Data were not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data were not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data were not collected

Validated global rating scale for assessing diagnostic knee arthroscopy performance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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'

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=13 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
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 Interval 1.5 to 2.1	3.3 Performance ratio (Participant:superviso Interval 2.2 to 4.8
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 Interval 2.8 to 4.7	10.3 Performance ratio (Participant:superviso Interval 5.1 to 11.9
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 Interval 1.1 to 1.7	2.6 Performance ratio (Participant:superviso Interval 1.6 to 3.0
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 Interval 1.8 to 2.8	4.3 Performance ratio (Participant:superviso Interval 2.8 to 5.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Simulation Training n=15 Participants 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	Non-simulation/Routine Training n=15 Participants Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Motion Analysis Parameters During Simulation	131 Hand movements Interval 108.0 to 153.0	249 Hand movements Interval 197.0 to 345.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data were not collected

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

Outcome measures

Outcome data not reported

Adverse Events

Simulation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-simulation/Routine Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr P Garfjeld Roberts

University of Oxford

Phone: 01865 227374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place