Arthroscopy TrainingNCT02777333
Simulation-based Arthroscopic Surgery Study
A study testing Simulation training in people with Arthroscopy Training, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroscopy Training
- What is being tested?
- Simulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide informed consent
- Previously completed higher surgical training programme
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7LD
About this study
The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).
Read the 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.
- Conditions
- Arthroscopy Training
- Being tested
- Simulation training
- Keywords
- Simulation, Arthroscopy, Motion analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingBehavioural
Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
| Study group | Role | What they receive |
|---|---|---|
| Simulation training | Experimental | Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Receives: Behavioral: Simulation training |
| Non-simulation/Routine training | No intervention | Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre
Validated global rating scale for assessing diagnostic knee arthroscopy performance
Measured: 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'
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Feasibility of Additional Simulation Training
Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroscopy TrainingStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan L Rees, FRCS-Tr&Orth, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777333
- Sponsor's protocol ID
- MSD-IDREC-C1-2014-152
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Arthroscopic Surgery Study
- ClinicalTrials.gov ID
- NCT02777333
- Acronym / sponsor ID
- MSD-IDREC-C1-2014-152
- Conditions
- Arthroscopy Training
- Keywords
- Simulation, Arthroscopy, Motion analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation training | Experimental | Behavioral: Simulation trainingAddition 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling or unable to provide informed consent
- Previously completed higher surgical training programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation trainingSimulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators | Behavioural | Simulation training |
Primary outcome
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 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.
14 secondary outcomes
Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre
Time frame: 3 months
Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Time frame: 3 months
Motion Analysis Parameters During Simulation
Time frame: 3 months
Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)
Time frame: 3 months
Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Time frame: 3 months
Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Time frame: 3 months
Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Time frame: 3 months
Feasibility of Additional Simulation Training
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Research group web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Mixed Reality vs. Traditional Arthroscopic Simulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan L Rees, FRCS-Tr&Orth principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training in people with Arthroscopy Training, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.