Simulation-based Arthroscopic Surgery Study
Phase: NA
Conditions: Arthroscopy Training
Sponsor: University of Oxford

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Study Title:  Simulation-based Arthroscopic Surgery Programme  
Internal Reference Number / Short title: Simulation-based Arthroscopic Surgery Programme 
Ethics Ref: MSD-IDREC-C1-2014-152 
Date and Version No: 16 Nov 2015 v4 
 
Chief Investigator: 
Prof Jonathan L Rees, Professor of Orthopaedic Surgery and 
Musculoskeletal Science, Nuffield Department of Orthopaedics, 
Rheumatology, and Musculoskeletal Sciences 
Investigators:  
Mr Patrick Garfjeld Roberts, DPhil Candidate, Nuffield Department of 
Orthopaedics, Rheumatology, and Musculoskeletal Sciences 
 
Sponsor:  
University of Oxford 
Funder: 
Royal College of Surgeons of England and NIHR Oxford Musculoskeletal 
Biomedical Research Unit 
Chief Investigator Signature:   
 
The investigators have no potential conflicts of interest. 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so. 
 

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TABLE OF CONTENTS 
To update table of contents (TOC), hover cursor over the table and ‘right click’.  Choose ‘update field’, 
then ‘update entire table’. 
 
1. 
SYNOPSIS ............................................................................................................................................... 4 
2. 
ABBREVIATIONS ..................................................................................................................................... 4 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 5 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................... 6 
5. 
STUDY DESIGN ....................................................................................................................................... 7 
6. 
PARTICIPANT IDENTIFICATION .............................................................................................................. 7 
6.1. 
Study Participants ........................................................................................................................... 7 
6.2. 
Inclusion Criteria ............................................................................................................................. 7 
6.3. 
Exclusion Criteria ............................................................................................................................ 8 
7. 
STUDY PROCEDURES ............................................................................................................................. 8 
7.1. 
Recruitment .................................................................................................................................... 8 
7.2. 
Screening and Eligibility Assessment .............................................................................................. 8 
7.3. 
Baseline assessment ....................................................................................................................... 8 
7.4. 
Randomisation ............................................................................................................................... 9 
7.1. 
Informed Consent ........................................................................................................................... 9 
7.2. 
Subsequent Sessions ...................................................................................................................... 9 
7.3. 
Discontinuation/Withdrawal of Participants from Study ............................................................. 10 
7.4. 
Definition of End of Study ............................................................................................................ 10 
8. 
STATISTICS AND ANALYSIS ................................................................................................................... 10 
8.1. 
Description of Statistical Methods ............................................................................................... 10 
8.2. 
The Number of Participants ......................................................................................................... 11 
9. 
DATA MANAGEMENT .......................................................................................................................... 11 
9.1. 
Access to Data .............................................................................................................................. 11 
9.2. 
Data Recording and Record Keeping ............................................................................................ 11 
10. 
QUALITY ASSURANCE PROCEDURES ................................................................................................. 12 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS ................................................................................. 12 
11.1. 
Declaration of Helsinki ............................................................................................................... 12 
11.2. 
Guidelines for Good Clinical Practice ......................................................................................... 12 
11.3. 
Approvals ................................................................................................................................... 12 
11.4. 
Reporting .................................................................................................................................... 13 

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11.5. 
Participant Confidentiality ......................................................................................................... 13 
11.6. 
Expenses and Benefits ................................................................................................................ 13 
11.7. 
Other Ethical Considerations ...................................................................................................... 13 
12. 
FINANCE AND INSURANCE ................................................................................................................ 13 
12.1. 
Funding ....................................................................................................................................... 13 
12.2. 
Insurance .................................................................................................................................... 14 
13. 
PUBLICATION POLICY ........................................................................................................................ 14 
14. 
APPENDIX C:  AMENDMENT HISTORY ............................................................................................... 15 
 
 
 

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1. SYNOPSIS 
Study Title 
‘Simulation-based Arthroscopic Surgery Programme’ (MSD-IDREC-C1-2014-
152) 
Internal ref. no. / short 
title 
 
Study Design 
Educational observational study 
Study Participants 
Healthy Volunteers from junior surgical trainees, and their consultants, 
working within the Oxford Deanery (Health Education Thames Valley) 
Planned Sample Size 
60 per year 
Planned Study Period 
5 years (to 2019) 
 
Objectives 
Outcome Measures 
Primary 
 
Assess the usefulness to training of 
the new elbow-attached motion 
sensors during diagnostic knee 
arthroscopy as part of routine 
consultant-supervised training in 
theatre 
Motion data, Global Rating Scales, 
Surgical logbook data 
Secondary 
Assess the usefulness to training of 
the new elbow-attached motion 
sensors during simulated arthroscopy 
in the skills lab  
Motion data, Surgical logbook data 
 
2. ABBREVIATIONS 
 
CCT 
Certificate of Completion of Training 
CI 
Chief Investigator 
CRF 
Case Report Form 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
GCP 
Good Clinical Practice 
GMC 
General Medical Council 
GP 
General Practitioner 
GRS 
Global Rating Scale 
HETV 
Health Education Thames Valley 
ICF 
Informed Consent Form 
MAT 
McLaren Applied Technology 
NHS 
National Health Service 
NRES 
National Research Ethics Service 

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OOSEC 
Oxford Orthopaedic Simulation and Education Centre 
PI 
Principal Investigator 
PIL 
Participant Information Leaflet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SAC 
Specialty Advisory Committee 
SOP 
Standard Operating Procedure 
 
3. BACKGROUND AND RATIONALE 
 
The ‘Simulation-based Arthroscopic Surgery Programme’ MSD-IDREC-C1-2014-152 aims to gather 
evidence for simulation training during surgical training. 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 show it improves surgical performance, and studies not been based on truly objective measurements. 
The ‘Simulation-based Arthroscopic Surgery Programme’ has the primary aim of developing evidence-
based simulation training by objectively justifying the use of simulation to improve surgical training. 
At the Oxford Orthopaedic Simulation and Education Centre (OOSEC) we are investigating new training 
methods for our future surgeons and using simulators, cadaver specimens and virtual reality models. To 
ensure evidenced based training we assess the learning and performance of the trainee groups using 
these various simulators. These groups mainly compromise surgical trainees, consultants and medical 
students and NHS ethics is not required, however to ensure best practice and as this work can lead to 
educational publications, we have ethical approval in place from CUREC (Simulation-based Arthroscopic 
Surgery Programme; MSD-IDREC-2014-152). In addition, and as part of an educational project, we will 
assess trainees in the real operating theatre as part of their usual training with their consultants, while 
patients receive their normal treatment. 
Motion analysis is a validated objective measure of technical skill used previously in simulated settings: 
numbers of hand movements and total path length have been shown to decrease with surgeon 
experience during simulated tasks. Typically, motion analysis involves wired sensors attached to the 
wrists that are unsuitable for use in theatre as the position interferes with sterile scrubbing. Our group 
has developed simple elbow-worn wireless motion sensors: besides using these sensors in the simulated 
setting it is now possible to also use them in the real operating theatre while trainees under go their 
normal training and assessments.  
Our study has CUREC approval to use surgical trainees as volunteers, and for technical skills assessments 
to take place in a simulated setting: we are seeking additional Trust approval to use elbow-worn wireless 
motion sensors during a routine consultant-supervised training list in the real operating theatre as an 
objective form of educational monitoring in addition to the methods already in use in their training 
programme curriculum portfolios (e.g. Practice-based Assessments, Directly Observed Procedures, 
Global Rating Scales). For the purpose of completeness, we also detail the specific features of this study 

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as part of the Simulation-based Arthroscopy Programme which occur in the simulated setting in the 
study description below. 
The sensors only gather surgical movement data and the trainers and trainees can then review their 
performance after the case to better understand and improve their training. The sensors themselves are 
safe to use in a clinical environment. They are securely attached to the surgeon’s elbows and do not 
interfere with thorough surgical scrubbing, nor do they interfere with any theatre equipment. They do 
not make contact with the patient, and are not attached or implanted in the patient. They do not involve 
the collection of any patient identifiable data, nor storage of tissue samples. As such, they pose no risk or 
interruption to standard theatre procedure. 
This study aims to investigate the use of a new form of educational monitoring during normal clinical 
practise, and this does not interfere with the delivery of normal patient care nor usual surgical practise. 
Risks: The presence of these sensors in theatre poses no additional risks or interruption to standard 
theatre procedure. 
Benefits: Participants will gain an understanding of their technical dexterity and skill. This may indicate 
areas of focus for practice, and may benefit patients by improving the learning curve in surgical trainees. 
They will make further possible the development of national evidenced based guidelines for arthroscopy 
training. 
Population: The participants wearing these sensors will be a mixture of core surgical trainees and 
specialist registrars on approved surgical training programmes, and their consultant supervisors. 
Typically these will be young healthy adults. 
Generalisable findings: Initially we aim to assess the motion parameters associated with diagnostic knee 
arthroscopy (a single repeatable arthroscopic tasks), but the concept and techniques of in theatre 
motion analysis could be generalised to all procedures where technical skills are required. The use of 
motion analysis intra-operatively means that surgical competence could be defined in terms of motion 
analysis parameters. Correlation between simulated and intra-operative measurements of these motion 
analysis parameters could be used to define a proficiency criterion in simulated pre-patient training 
before performing surgery in theatre, or motion analysis parameter correlation with the number of 
procedures performed could be used to advise the SAC when defining the indicative numbers of 
procedures required to achieve CCT. 
4. OBJECTIVES AND OUTCOME MEASURES 
Objectives 
Outcome Measures  
Timepoint(s) of evaluation of this 
outcome measure (if applicable) 
Primary Objective 
Assess the usefulness of the 
new elbow-attached motion 
sensors during diagnostic 
knee arthroscopy as part of 
routine, consultant-
Motion analysis parameters during 
consultant-supervised 
diagnostic 
knee arthroscopy 
Global 
rating 
scale 
during 
consultant-supervised 
diagnostic 
At 3 months follow up, as part of 
and during the CUREC-approved 
‘Simulation-based 
Arthroscopic 
Surgery Programme’ MSD-IDREC-
2014-152  

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supervised training in theatre 
knee arthroscopy 
Secondary Objective 
Assess the usefulness to 
training of the new elbow-
attached motion sensors 
during simulated arthroscopy 
in the skills lab 
Motion analysis parameters during 
simulated arthroscopy in the Skills 
lab 
At baseline and after 3 months,  
 
 
5. STUDY DESIGN 
The ‘Simulation-based Arthroscopic Surgery Programme’ MSD-IDREC-2014-152 is a CUREC-approved 
series of studies investigating the effect of new training methods for our future surgeons and using 
simulators, cadaver specimens and virtual reality models. These studies involve the assessment of 
trainee groups (including junior surgical trainees, specialist registrars and consultants) in two ways: 
1 – on simulators, using metrics such as motion analysis data, global rating scales and participant 
feedback 
2 – in theatre, using metrics such as global rating scales, procedure based assessments and participant 
feedback.  
In this particular sub-study, we are recruiting up to 60 junior surgical trainees in T&O posts as part of 
their training programme. These will all undergo a baseline assessment on an arthroscopic simulator, 
after which they will be randomised 50:50 to either a control group (regular training i.e. their T&O post) 
or an experimental group (additional simulation training approx.. 1 hour per week) for the next three 
months. At 3 months they will undergo repeat assessment on the arthroscopic simulator, and in theatre. 
Participants will use simple elbow-worn wireless motion sensors during simulation assessments and 
simulation training, and during usual training in theatre under consultant-supervision, while the patients 
received their normal treatment, to assess their effectiveness at monitoring learning and performance in 
addition to the usual forms of educational monitoring above. Over the course of the study, surgical 
logbook/training data will be collected by the participant and linked to their other results anonymously. 
6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
Healthy volunteers from the deanery training programme at junior surgical trainee and specialist 
registrar level, plus consultant orthopaedic surgeons 
6.2. Inclusion Criteria 

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• 
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; or supervising Orthopaedic Consultant. 
6.3. Exclusion Criteria 
The participant may not enter the study if ANY of the following apply: 
• 
Unwilling or unable to provide informed consent 
 
7. STUDY PROCEDURES 
7.1. Recruitment 
The ‘Simulation-based Arthroscopic Surgery Programme’ MSD-IDREC-2014-152 recruits junior surgical 
trainees, specialist registrars, and their supervising consultants from the Oxford Deanery for simulation 
training using simple elbow-worn wireless motion sensors. Recruitment takes place using emailed 
adverts sent via clinical and academic departments e.g. newsletters. In this particular sub-study, we are 
recruiting up to 60 junior surgical trainees in T&O posts as part of their training programme. Those who 
express an interest to the invite circulated by the Deanery/Trust will be provided with a participant 
information sheet and have the opportunity to discuss this with an investigator. Those wishing to 
proceed will be invited to attend a baseline session where eligibility and consent are confirmed in person 
after the participant has the opportunity to ask any further questions regarding the study or participant 
information sheet. 
7.2. Screening and Eligibility Assessment 
The invitation emails will be sent to those who fit the recruitment group by the Deanery and the Trust. 
Of those responding and expressing an interest, the eligibility criteria (namely employed in a T&O post at 
a junior surgical level in the OUH Foundation Trust; consenting to take part) will be confirmed before 
proceeding to arrange any assessments. 
7.3. Baseline assessment 
The first session will be a baseline meeting where eligibility and consent are confirmed once the 
participants questions regarding the previously provided information sheet are answered. Baseline 
simulator performance data using motion analysis will be gathered, plus some basis demographic data 
and information about surgical experience. They will also be asked to keep a note of all surgical 
procedures they perform in the coming 3 months. They will also be randomised to the control (usual 
training) or experimental (additional simulation training) group. This meeting will take about 45-60 
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7.4. Randomisation 
At the first meeting after their baseline simulation assessment, they will be randomised by sealed 
envelopes method to either control or experimental groups. As the participant will be attending 
simulation training, they cannot be blinded to this, but they will be provided with a unique identifier for 
use during the motion capture which will allow the data to be recorded anonymously and analysed 
blindly as to the randomisation. 
7.5. Informed Consent 
For each study in the ‘Simulation-based Arthroscopic Training Programme’ the participant must 
personally sign and date the latest approved version of the Informed Consent form before any study 
specific procedures are performed. This takes place at the baseline assessment. 
Written and verbal versions of the Participant Information and Informed Consent will be presented to 
the participants detailing no less than: the exact nature of the study; the presence of randomisation in 
the protocol; what it will involve for the participant; the implications and constraints of the protocol; the 
known side effects and any risks involved in taking part. It will be clearly stated that the participant is 
free to withdraw from the study at any time for any reason without prejudice to future care, without 
affecting their legal rights, and with no obligation to give the reason for withdrawal. 
The participant will be allowed as much time as wished to consider the information, and the opportunity 
to question the Investigator, or other independent parties to decide whether they will participate in the 
study. Written Informed Consent will then be obtained by means of participant dated signature and 
dated signature of the person who presented and obtained the Informed Consent. The person who 
obtained the consent must be suitably qualified and experienced, and have been authorised to do so by 
the Chief/Principal Investigator. A copy of the signed Informed Consent will be given to the participant. 
The original signed form will be retained at the study site. 
7.6. Subsequent Sessions 
Those randomised to the experimental group will be asked to attend for 1 hour per week over the next 3 
months at the Skills lab in the Nuffield Orthopaedic Centre for regular simulation training. Motion data 
may also be recorded during these sessions. 
At 3 month follow up, all participants will repeat a simulated arthroscopy assessment lasting about 30-45 
mins, similar to that which occurred at baseline, and an in theatre assessment using the same wireless 
elbow sensors. We aim to coordinate these two events in the same visit. 
Junior surgical trainees perform surgery under consultant supervision as part of their training 
programme. It is during one of these surgical cases, we will gather objective surgical motion data in 
addition to the usual forms of educational evaluation which take place as part of training. 
Participants will attend a consultant supervised knee arthroscopy list at the Nuffield Orthopaedic Centre. 
The participant and consultant will have the wireless sensors attached to their elbows by adhesive tape 
or custom sleeves that fit to the elbow. They are securely attached to the surgeon’s elbows and do not 
interfere with thorough surgical scrubbing, nor do they interfere with any theatre equipment. The 
participant will scrub for the case with the consultant. The consultant will perform the procedure the 
patient has been admitted for, and once complete, will demonstrate a diagnostic knee arthroscopy (a 

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keyhole video examination of all the structures within the knee) to the participant as per standard 
surgical training practise. The consultant will then supervise the participant performing the same 
procedure as would normally happen during surgical training. They will provide the same support, and 
interrupt the procedure as they would in any other supervised surgical case if they feel this is necessary. 
Participants motion analysis parameters will be compared to those of the supervising consultant, which 
will act as a bench-marking process to account for the technical differences between cases (e.g. the 
weight or size of the leg). This wireless motion data will be recorded to assess the elbow sensors’ 
effectiveness at monitoring learning and performance in addition to the usual forms of educational 
monitoring e.g. Procedure-base assessments and global rating scales. 
 
7.7. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the Investigator may 
discontinue a participant from the study at any time if the Investigator considers it necessary for any 
reason including: 
• 
Ineligibility (either arising during the study or retrospectively having been overlooked at 
screening) 
• 
Significant protocol deviation 
• 
Significant non-compliance with treatment regimen or study requirements 
• 
Withdrawal of Consent 
• 
Loss to follow up 
• 
Exclusion from core or higher surgical training programme 
 
The reason for withdrawal, if disclosed, will be recorded in the Case Report Form. 
7.8. Definition of End of Study 
The CUREC-approved ‘Simulation-Based Arthroscopic Surgery Programme’ will allow the repeated 
practice of technical tasks in a safe environment, whilst posing no risk to patient or learner. Our aim is to 
assess the effectiveness of simulation based arthroscopic training and to see whether it may have a role 
in surgical training. More specifically, we will assess the usefulness to training of the new elbow-attached 
motion sensors during routine, consultant-supervised procedures in theatre. 
This research programme will take place over a five year period in the “Oxford Orthopaedic Simulation & 
Education Centre” which is situated within the Nuffield Department of Orthopaedics, Rheumatology and 
Musculoskeletal Science. This period expires in 2019. 
8. STATISTICS AND ANALYSIS 
8.1. Description of Statistical Methods 

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Motion analysis data from the elbow-worn wireless motion sensors produces similar data to the wired 
sensors our group has used previously. 
Number of movements and path length are common to both devices. Data distributions will be assessed 
for normality. Previous studies show such data are not normally distributed and we would expect to use 
non-parametric tests, in this case the Mann-Whitney U test or Kruskall-Wallis test, to compare 
performance between groups during a given task. Mann-Whitney U tests will also be used within a group 
to compare performance before and after training on a simulator.  
Surgical logbook data will be assessed using descriptive statistics, and motion analysis performance will 
be reported with reference to surgical experience. 
Questionnaire data regarding the trainee and consultant perception of the utility of these sensors will be 
reported as descriptive statistics. 
8.2. The Number of Participants 
We plan to use these elbow-worn wireless motion sensors during as an additional educational 
monitoring tool during normal surgical training. We have not set a limit on the participant numbers 
(although up to 60 participants per year is possible). More participants to the studies within ‘Simulation-
based Arthroscopic Surgery Programme’ at all stages will allow us to monitor their performance and 
develop performance curves, to show how motion analysis parameters change with surgical experience. 
9. DATA MANAGEMENT 
9.1. Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
OOSEC research team members will have access to raw motion data, and output metrics generated from 
the raw data. By unique identifiers, this can be matched to other metrics during the Simulation-based 
Arthroscopic Surgery Programme, but not de-anonymised to reveal participants or patients.  
Our collaborator computer at MAT will have access to the raw motion data, and use this to produce 
algorithms to generate the performance output metrics. They will not require access to any files that 
matches participants to their unique identifiers, nor to non-motion sensor data generated by participants 
elsewhere in the study. As such, MAT computer scientists will not be able to link any motion data to 
participants. 
9.2. Data Recording and Record Keeping 
Anonymised non-personal raw motion data will be uploaded to secure off-site servers using SSL/TLS 
using strong cipher suites that support perfect forward secrecy. This prevents decoding of captured data, 
even if the secret long-term key itself is compromised. Every instance has a built in firewall that is 
configured using a least privilege basis and will only accept https (port 443) connections from the 

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internet. The data centres are staffed 24x7 by trained security guards and access is authorised strictly on 
a least privileged basis. 
This data will be remain anonymised regards to the participant, and will contain no information that 
related to patients. The raw motion data can be queried to generate usable motion analysis metrics (e.g. 
smoothness, hand movements etc). These are not stored on the server, but generated on request via 
proprietary algorithms. Pooled anonymised non-personal raw data from participants’ motion data is 
used to generate and refine the algorithms, and as such, as more raw data is acquired by the server, the 
requested outputs become more accurate. Pooled data cannot extracted to be attributed to any 
participant. 
Usable output motion analysis metrics will be downloaded form the server and stored locally on an Excel 
spreadsheet (.xlsx). These data may be opened in other programmes or copied to other formats for 
certain analyses e.g. SPSS data files (.sav). Where study data are generated in a proprietary file type, 
these will be transposed to Excel format. 
The participants will be identified by a unique study specific number and/or code in any database.  The 
name and any other identifying detail will NOT be included in any study data electronic file. All study 
data files will be kept on password protected hard-drives. Output study data will be kept for a further 3 
years following the completion of the study before being destroyed. Anonymised non-personal raw data 
from the sensors will contribute to the algorithm on the secure server, but will not be extractable or 
identifiable to any participant. 
10. QUALITY ASSURANCE PROCEDURES 
The study will be conducted in accordance with the current approved protocol, GCP, relevant regulations 
and standard operating procedures, may be monitored, or audited against these. 
 
11. ETHICAL AND REGULATORY CONSIDERATIONS 
11.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
11.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
11.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed advertising 
material will be submitted to an appropriate Research Ethics Committee (REC), and host institution(s) for 
written approval. 

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The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
11.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
REC Committee, host organisation and Sponsor.  In addition, an End of Study notification and final report 
will be submitted to the same parties. 
11.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be 
identified only by a participant ID number on all study documents and any electronic database, with the 
exception of the CRF, where participant initials may be added.  All documents will be stored securely and 
only accessible by study staff and authorised personnel. The study will comply with the Data Protection 
Act, which requires data to be anonymised as soon as it is practical to do so. 
11.6. 
Expenses and Benefits 
No payments are intended for the participants. Participants may receive benefit from access to 
simulation training, and any technical skills development that may result. 
11.7. 
Other Ethical Considerations 
The aims of this project are to develop a novel method of educational monitoring: some monitoring will 
take place in a patient setting (the operating theatre), but does not involve the alteration of patient 
treatment.  
The wireless sensors are safe to use in a clinical environment. They are securely attached to the 
surgeon’s elbows and do not interfere with thorough surgical scrubbing, nor do they interfere with any 
theatre equipment. They do not make contact with the patient, and are not attached or implanted in the 
patient. They do not involve the collection of any patient identifiable data, nor storage of tissue samples. 
As such, they pose no risk or interruption to standard theatre procedure. 
The methods of assessing technical skills being investigated by these studies are experimental. As such, 
these will not be used to draw conclusions about a trainee’s performance with regards to the 
requirements of the training programme, and will not be available to the Deanery for ARCP evaluations. 
So as participants randomised to the control group are not disadvantaged in terms of training 
opportunities, they will be offered the simulation training experience by the experimental group free of 
charge when they have completed their participation in the study. 
12. FINANCE AND INSURANCE 
12.1. 
Funding 
Dinwoodie Simulation Research Fellowship funded by Royal College of Surgeons of England 

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NIHR Oxford Musculoskeletal Biomedical Research Unit 
12.2. 
Insurance 
The University has a specialist insurance policy in place which would operate in the event of any 
participant suffering harm as a result of their involvement in the research (Newline Underwriting 
Management Ltd, at Lloyd’s of London).  NHS indemnity operates in respect of the clinical treatment that 
is provided. 
 
13. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authors will acknowledge that the study was funded by 
Royal College of Surgeons of England Dinwoodie Research Fellowship and NIHR Oxford Musculoskeletal 
Biomedical Resreach Unit. Authorship will be determined in accordance with the ICMJE guidelines and 
other contributors will be acknowledged. 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study. Authors will acknowledge that the study was funded by 
NIHR Oxford Musculoskeletal Biomedical Research Unit. Authorship will be determined in accordance 
with the ICMJE guidelines and other contributors will be acknowledged. The findings will also be used 
towards a DPhil thesis for Patrick Garfjeld Roberts.  
Participants will be alerted to publication of findings via email. 
 
 

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14. APPENDIX C:  AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made 
1 
1.0 
26 June 
2015 
P Garfjeld Roberts 
Use of McLaren Server to 
store anonymous data 
generated from  motion 
sensors; retain data at 
end of project 
2 
1.0 
31 July 
2015 
P Garfjeld Roberts 
Elbow sensors added (as 
technically Class B 
Invasive, being attached 
to particpant) 
3 
1.0 
5 Nov 
2015 
P Garfjeld Roberts 
Additional consent for 
study data in future 
studies; consent for 
logbook data; change in 
population to junior 
orthopaedic trainees 
4 
1.0 
16 Nov 
2015 
P Garfjeld Roberts 
Clarification of aspects of 
Simulation Based 
Arthroscopic Surgery 
programme relevant to 
this study (previously 
only mentioned theatre)