Simulation-based arthroscopic surgery study
| ISRCTN | ISRCTN27154417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27154417 |
| ClinicalTrials.gov number | NCT02777333 |
| Secondary identifying numbers | MSD-IDREC-C1-2014-152 |
- Submission date
- 09/05/2016
- Registration date
- 28/07/2016
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Surgeons in training are taught a range of skills, including technical skills, communication, clinical knowledge and anatomy, and decision making. On a background of decreasing working time available, less independent operating, and greater public expectations of the medical profession, simulation is seen as an important support to routine surgical training. However, there is little evidence to say it improves surgical performance, and these studies are not based on factual measurements but rather opinions. The aim of this study is to use motion analysis to specifically assess the technical skills aspects of surgical training, and in order to find out whether simulation training can improve performance.
Who can participate?
Adults enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in normal clinical training alone. Those in the second group take part in one hour additional simulation training a week for thirteen weeks. The simulation sessions themselves involve self-directed practice on bench-top simulators, which monitor performance using wireless elbow mounted motion sensors recording hand movements, smoothness of hand movements and time taken.
What are the possible benefits and risks of participating?
The main benefits of participating are the additional training opportunities given. These will also be offered to those who take part in usual training alone at the end of the study. There are no notable risks involved with participating.
Where is the study run from?
Nuffield Orthopaedic Centre (UK)
When is the study starting and how long is it expected to run for?
March 2015 to January 2017
Who is funding the study?
Royal College of Surgeons of England (UK)
Who is the main contact?
Mr Patrick Garfjeld Roberts
Contact information
Scientific
Botnar Research Centre
University of Oxford
Windmill Road
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0003-2316-5089 |
|---|---|
| Phone | +44 1865 227 374 |
| patrick.garfjeldroberts@ndorms.ox.ac.uk |
Study information
| Study design | Single blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Does simulation training improve intra-operative arthroscopic technical skills performance in junior orthopaedic trainees? |
| Study objectives | That the addition of simulation training improves arthroscopic technical skills performance of junior orthopaedic trainees during knee arthroscopy in the operating theatre compared to usual clinical training programme. |
| Ethics approval(s) | Medical Sciences Interdivisional Research Ethics Committee, University of Oxford, 12/09/2014, ref: MSD-IDREC-C1-2014-152 |
| Health condition(s) or problem(s) studied | Arthroscopic surgery training |
| Intervention | Participants are randomly allocated to one of two groups using a blocked randomisation with random block sizes and a 1:1 allocation ratio. Control/Non-simulation study arm: Participants will receive no additional treatment/training beyond their usual day to day clinical work as a senior house officer level trainee (including but not limited to: ward work, attending theatre, clinics, out-of-hours/‘on-call’) for the 13 weeks of the study. Intervention/simulation study arm: Participants will receive weekly 1 hour simulation sessions over 13 weeks at the skills lab at the Nuffield Orthopaedic Centre, arranged on an individual basis to fit around clinical commitments. The simulation sessions will involve self directed practice on non-anatomical and anatomic arthroscopic bench-top simulators (#1711-1 and #1517-29-11 available from SawBones, Malmo, SE), during which they can monitor their performance using wireless elbow mounted motion sensors recording hand movements, smoothness of hand movements and time taken. Total duration is 13 weeks in both groups. Both groups will be followed up at 13 weeks, with no planned further follow up. |
| Intervention type | Behavioural |
| Primary outcome measure | Motion analysis parameters ('hand movements', 'minor hand movements', 'smoothness of movements', 'time taken', 'maximum hand acceleration', 'stationary time', 'idle time' and 'hand dominance') are measured using wireless elbow mounted motion sensors during diagnostic knee arthroscopy at 3 months. |
| Secondary outcome measures | 1. Performance during diagnostic knee arthroscopy is measured using the Global rating scale at 3 months 2. Motion analysis parameters as a function of 'ideal' motion analysis parameters are judged by a supervising clinician during the same case at 3 months 3. Change in simulator performance using motion analysis parameters at baseline and 3 months 4. Structural and functional changes on fMRI using resting state networks, voxel based morphometry, diffusion tractography and quantitative magnetisation transfer is measured at 3 month follow up by comparison to baseline fMRI 5. Feasibility of simulation training during usual clinical training is measured using a qualitative survey designer for this study at 3 month follow up |
| Overall study start date | 03/03/2015 |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2. Healthy adults, Male or Female, aged 18 years or above 3. Enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts |
| Key exclusion criteria | 1. Unwilling or unable to provide informed consent 2. Previously completed higher surgical training programme |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 01/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford
OX3 7LD
United Kingdom
Sponsor information
University/education
Clinical Trials & Research Governance | Research Services
University of Oxford
Joint Research Office, Block 60, Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
| Phone | +44 1865 572221 |
|---|---|
| karl.shepherd@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of this study will contribute to a DPhil thesis, and will be submitted to academic peer reviewed journals and conferences, likely with an orthopaedic, arthroscopic or medical education focus. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | 09/08/2019 | Yes | No |
Editorial Notes
09/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT code has been added.
