A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
Phase: NA
Conditions: Hip Osteoarthritis
Sponsor: University of Oxford

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
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Study Title:  A prospective randomised controlled study assessing the impact of simulation training in 
primary total hip replacement (THR). 
 
Internal Reference Number / Short title: THR Performance & Assessment 
Ethics Ref: 19/SC/0492 
IRAS Project ID: 270167 
Date and Version No: 6th August 2019, Version 1.0 
 
Chief Investigator: 
Professor Jonathan Rees 
Professor of Orthopaedic Surgery and Musculoskeletal Science 
Nuffield Department of Orthopaedics, Rheumatology, and 
Musculoskeletal Sciences (NDORMS). 
Honorary Consultant Orthopaedic Surgeon 
Nuffield Orthopaedic Centre (NOC) 
Oxford University Hospitals NHS Foundation Trust 
 
Investigators:  
Mr Daniel Howgate 
Honorary Specialty Registrar in Trauma & Orthopaedic Surgery 
Oxford University Hospitals NHS Foundation Trust. 
Royal College of Surgeons (RCS) of England and Dinwoodie Charitable 
Company Research Fellow 
Nuffield Department of Orthopaedics, Rheumatology, and 
Musculoskeletal Sciences (NDORMS). Botnar Research Centre 
 
Mr Ben Kendrick 
Consultant Orthopaedic Surgeon 
Nuffield Orthopaedic Centre (NOC) 
Oxford University Hospitals NHS Foundation Trust 
 
Sponsor:  
University of Oxford/Clinical Trials and Research Governance 
Joint Research Office, 
1st Floor Boundary Brook House, 
Churchill Drive, 
Headington, 
OX3 7GB 
 
 
Funder: 
Dinwoodie Charitable Company 
 
 
Chief Investigator Signature:  
 
 
 
 
Statistician Signature: We do not require a dedicated statistician for data analysis of this particular study. 
However, if required we have access to many statisticians in the Centre for Statistics in Medicine (CSM) 
and our Trials Unit within the Botnar Research Centre. 
 
The investigators have no potential conflicts of interest to declare. 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, HRA, host organisation, and members of the Research Ethics Committee,  

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TABLE OF CONTENTS 
 
1. 
KEY CONTACTS ................................................................................................................ 4 
2. 
LAY SUMMARY ................................................................................................................. 4 
3. 
SYNOPSIS ............................................................................................................................ 5 
4. 
ABBREVIATIONS............................................................................................................... 7 
5. 
BACKGROUND AND RATIONALE ................................................................................. 8 
6. 
OBJECTIVES AND OUTCOME MEASURES .................................................................. 9 
7. 
STUDY DESIGN ................................................................................................................ 10 
Please see Appendix A for study flow diagram. ........................................................................ 10 
8. 
PARTICIPANT & PATIENT IDENTIFICATION ............................................................ 11 
8.1. 
Consultants, Fellows, and Specialty Registrars ........................................................... 11 
Inclusion Criteria ........................................................................................................................ 11 
Exclusion Criteria ....................................................................................................................... 11 
8.2. 
Patients ......................................................................................................................... 12 
Inclusion Criteria ........................................................................................................................ 12 
Exclusion Criteria ....................................................................................................................... 12 
9. 
PROTOCOL PROCEDURES ............................................................................................. 12 
9.1. 
Recruitment .................................................................................................................. 12 
9.1.2 
Patient Recruitment...................................................................................................... 12 
9.2. 
Informed Consent ........................................................................................................ 13 
9.3. 
Subsequent Visits ......................................................................................................... 13 
9.4 
Randomisation ............................................................................................................. 14 
9.5 
Blinding and code-breaking ......................................................................................... 14 
9.6 
Description of study intervention(s),  .......................................................................... 14 
9.7 
Intra-operative surgeon performance data collection  ................................................. 15 
9.8 
Protocol Early Discontinuation/Withdrawal of Participants ....................................... 15 
9.9 
Definition of End of Study........................................................................................... 16 
10 
SAFETY REPORTING ...................................................................................................... 16 
10.4 
Definition of Serious Adverse Events ......................................................................... 16 
10.5 
Reporting Procedures for Serious Adverse Events ...................................................... 17 
11 
STATISTICS AND ANALYSIS ........................................................................................ 17 
12 
DATA MANAGEMENT .................................................................................................... 18 
12.4 
Source Data .................................................................................................................. 19 
12.5 
Access to Data ............................................................................................................. 20 
12.6 
Data Recording and Record Keeping .......................................................................... 20 

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13 
QUALITY ASSURANCE PROCEDURES ....................................................................... 21 
13.4 
Risk assessment ........................................................................................................... 21 
13.5 
Study monitoring ......................................................................................................... 21 
13.6 
Study Committees ........................................................................................................ 21 
14 
PROTOCOL DEVIATIONS .............................................................................................. 21 
15 
SERIOUS BREACHES ...................................................................................................... 21 
16 
ETHICAL AND REGULATORY CONSIDERATIONS .................................................. 21 
16.4 
Declaration of Helsinki ................................................................................................ 21 
16.5 
Guidelines for Good Clinical Practice ......................................................................... 21 
16.6 
Approvals ..................................................................................................................... 22 
16.7 
Other Ethical Considerations ....................................................................................... 22 
16.8 
Reporting ..................................................................................................................... 22 
16.9 
Participant Confidentiality ........................................................................................... 22 
16.10 
Expenses and Benefits ................................................................................................. 22 
17 
FINANCE AND INSURANCE .......................................................................................... 23 
17.4 
Funding ........................................................................................................................ 23 
17.5 
Insurance ...................................................................................................................... 23 
17.6 
Contractual arrangements ............................................................................................ 23 
18 
PUBLICATION POLICY ................................................................................................... 23 
19 
DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF 
INTELLECTUAL PROPERTY..................................................................................................... 23 
20 
ARCHIVING ...................................................................................................................... 23 
21 
REFERENCES .................................................................................................................... 23 
22 
APPENDIX A:  STUDY FLOW CHART .......................................................................... 25 
23 
APPENDIX B:  SCHEDULE OF STUDY PROCEDURES FOR PATIENTS ................. 26 
24 
APPENDIX C:  Wireless Motion Sensors .......................................................................... 27 
25 
APPENDIX D:  AMENDMENT HISTORY ...................................................................... 28 
 
 
 

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1. KEY CONTACTS 
 
Chief Investigator 
Professor Jonathan Rees 
Professor of Orthopaedic Surgery and Musculoskeletal Science 
Nuffield Department of Orthopaedics, Rheumatology, and 
Musculoskeletal Sciences (NDORMS). 
Honorary Consultant Orthopaedic Surgeon 
Nuffield Orthopaedic Centre (NOC), Oxford University Hospitals NHS 
Foundation Trust 
E-mail: jonathan.rees@ndorms.ox.ac.uk 
Work Tel: 01865737540 
Sponsor 
University of Oxford/Clinical Trials and Research Governance 
Joint Research Office, 
1st Floor Boundary Brook House, 
Churchill Drive, 
Headington, 
OX3 7GB 
Funder(s) 
Dinwoodie Charitable Company                                                                        
4 Tytherington Green, Macclesfield, SK10 2FA                                   
E-mail: dinwoodie@irwinmitchell.com                                                  
Tel: 01625610549                                                                               
Charity no. 1151139                                                                                 
Company no. 08391977 
Statistician 
N/A 
Committees 
N/A 
 
 
 
2. LAY SUMMARY  
 
This research study is focused upon assessing and optimising surgeon’s performance during, and patient 
outcomes following, total hip replacement (THR) surgery. The primary research question is to determine 
if additional simulation training can improve the intra-operative performance of surgical trainees 
(Specialty Registrars) during a THR, or the outcome of patients after their THR. We will also aim to define 
an ‘expert’ standard in performing a primary elective THR, which may be used as a benchmark when 
assessing surgical trainee performance; and also determine if operative surgeon performance metrics 
during a THR are correlated with surgical experience, or patient outcomes. 
 
The surgeon participants in this study will be divided into 2 groups depending upon their position and 
seniority. The ‘Expert’ group will be composed of Consultant Orthopaedic Surgeons and Senior Fellows, 
and the ‘Trainee’ group will be composed of Trauma & Orthopaedic Specialty Registrars (StR’s) on Deanery 
clinical placements. The intervention to be tested is the simulation-based training and cognitive learning 
package. This will be delivered for 1-2 hours per week over a 4-week period in a supervised non-clinical 
setting to a randomised sub-group of 50% of the Specialty Registrars enrolled into this study. Surgeon 
participants within the Expert group will not undergo any interventions. 
 

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The outcome measures will be surgeon-specific and patient-specific. These outcome measures for the 
‘Trainee’ group will commence following completion of the simulation training (if applicable), whereas 
they can commence immediately following study approval for the ‘Expert’ group. The surgeon-specific 
outcome measures will be the objective motion-analysis metrics generated by validated and extensively 
used wireless sensors placed on the elbows of surgeons under their sterile gowns during the operation; 
and subjective assessments of surgical trainee performance using validated and reliable forms of 
structured human grading. Patient-specific outcome measures will be collected for a pre-determined 
number of patients who have undergone a primary elective THR by any of the surgeon participants in this 
study. All patient-specific outcome measures (with the exception of a post-operative questionnaire) are 
routinely collected as part of the patients NHS clinical care, and no other additional investigations are 
required for conducting this research. All patients will be asked to provide their written informed consent 
for the use of their data in this study. The patient-specific outcome measures include: pre- and post-
operative blood tests and radiograph (X-ray) analysis; the incidence of blood transfusions and any other 
peri-operative complications; the in-patient length of stay; and two patient-reported outcome measure 
(PROMs) questionnaires. 
 
Statistical analysis will then be performed on the data collected, specifically aiming to identify any 
significant differences in either surgeon performance metrics, or patient outcome measures between: 
 
1) The StR’s who have undertaken additional simulation training versus those who have routine 
Deanery training. 
2) The ‘Trainee’ group and the ‘Expert’ group. A sub-group analysis may be performed within the 
‘Expert’ group also to determine any differences between the Consultants and Fellows. 
 
In summary, this novel research will use validated methodology and routinely collected patient outcome 
measures in order to determine the impact of simulation training on surgical trainee performance and 
patient outcomes following a primary elective THR, and also help to benchmark an expert level of 
performance in this commonly performed and highly effective operation. The results of this study will 
hopefully help in shaping the future of orthopaedic surgical training and assessment within the United 
Kingdom. 
 
3. SYNOPSIS 
 
Study Title 
A prospective randomised controlled study assessing the impact of simulation 
training in primary total hip replacement (THR). 
Short title 
THR Performance & Assessment 
Study registration 
IRAS Project ID: 270167 
6th August 2019  
Sponsor  
University of Oxford/Clinical Trials and Research Governance 
Joint Research Office, 
1st Floor Boundary Brook House, 
Churchill Drive, 
Headington, 
OX3 7GB 

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Funder  
Dinwoodie Charitable Company 
Study Design 
Prospective randomised controlled study, with an additional comparator group. 
Study Participants 
Trauma & Orthopaedic Specialty Registrars (intervention and control groups), 
Consultant Orthopaedic Surgeons, and Arthroplasty Fellows. 
Patients undergoing elective primary THR at the 2 named NHS Hospitals in this 
study, when their lead surgeon is enrolled as a participant in this study. 
Participant Sample 
Size 
Surgeon participant Group 1 a: Interventional group (‘StR’s’): Thames Valley Deanery 
Trauma & Orthopaedic Specialty Registrars on Arthroplasty clinical placements (n=8) 
receiving additional training   
 
Surgeon participant Group 1 b: control group (StR’s): Thames Valley Deanery Trauma 
& Orthopaedic Specialty Registrars on Arthroplasty clinical placements receiving 
routine and normal Deanery training only (n=8). 
 
Surgeon participant Group 2: (‘Experts & Fellows’): Consultant Orthopaedic 
Surgeons (n=5), and nationally appointed Arthroplasty Fellows (n=8). 
 
Patient Participants: Estimated total n= 193, calculated on the basis of outcomes 
data following THR to be collected for: 
8 patients per Specialty Registrar (n = 128)  
5 patients per Fellow (n = 40) 
5 patients per Consultant (n = 25) 
Planned Study 
Period 
Total length of project = 18-24 months 
Length of individual participants involvement = 6 months 
Planned 
Recruitment period 
Start date for recruitment = August 2019 
End date for recruitment = February 2021 (with possible extension to August 2021) 
 
Objectives 
Outcome Measures 
Timepoint(s) 
Primary 
 
To assess the 
impact of 
simulation 
training on 
surgical trainee 
performance and 
patient outcomes 
following THR. 
Participants: 
• 
Wireless motion data metrics 
from elbow worn sensors 
(hand movements, path 
length and time taken). 
• 
Global Rating Scales (GRS). 
• 
Objective Structured 
Assessment of Technical 
Skills (OSATS). 
• 
Surgical checklists. 
 
Patients: 
• 
X-ray analysis of THR.[4]  
• 
Blood loss and transfusion 
rates. 
 
Intra-operative 
assessments to be 
performed at a 
minimum of 8 
separate THR 
operations for each 
participant in Group 1 
(StR’S) over a 6-
month period. 
 
Outcome measures 
data will be collected 
for all patients who 
have had a THR 
performed by any 
participant as the 

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• 
Peri-operative patient 
morbidity  
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
lead surgeon in this 
study. 
Secondary 
 
To define an 
expert standard 
when performing 
a primary elective 
THR. 
 
To determine if 
operative surgeon 
performance 
metrics during a 
THR relate to 
surgical 
experience, or 
patient outcomes. 
Participants: 
• 
Wireless motion data metrics 
from elbow worn sensors 
(hand movements, path 
length and time taken). 
 
Patients: 
• 
X-ray analysis of THR.[4]  
• 
Blood loss and transfusion 
rates. 
• 
Peri-operative patient 
morbidity  
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
Intra-operative 
assessments at a 
minimum of 5 
separate THR 
operations for each 
participant in Group 2 
(Experts & Fellows). 
 
Outcome measures 
data will be collected 
for all patients who 
have had a THR 
performed by any 
participant as the 
lead surgeon. 
Intervention(s) 
The intervention to be tested is the simulation-based training and cognitive learning 
package. This will be delivered in a supervised non-clinical laboratory setting to a 
randomised sub-group of 50% of the participants within the ‘StR’ group.  
 
4. ABBREVIATIONS 
AF’s 
Arthroplasty Fellows 
CCT 
Certificate of Completion of Training 
CI 
Chief Investigator 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
CUREC 
Central University Research Ethics Committee 
DGH 
District General Hospital 
EPR 
Electronic Patient Record  
EQ-5D 
EuroQol-5D 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
GRS 
Global Rating Scales 
HRA 
Health Research Authority 
ICF 
Informed Consent Form 
LOS 
Length of stay 
MS-IDREC 
Medical Sciences Inter-Divisional Research Ethics Committee 

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NDORMS 
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences 
NHS 
National Health Service 
NICE 
National Institute for Health and Clinical Excellence 
NJR 
National Joint Registry 
NOC 
Nuffield Orthopaedic Centre 
OHS 
Oxford Hip Score 
OOSEC 
Oxford Orthopaedic Simulation & Education Centre 
OPD 
Out-Patient Department 
OUH 
Oxford University Hospitals 
PACS 
Picture Archiving and Communication System 
PI 
Principal Investigator 
PIC 
Participant Informed Consent 
PIS 
Participant Information Sheet 
POAC 
Pre-operative assessment clinic  
PROMs 
Patient-Reported Outcome Measures 
PSA 
Procedure-Specific Assessments 
QALY 
Quality-Adjusted Life Year 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
RES 
Research Ethics Service 
SOP 
Standard Operating Procedure 
StR 
Specialty Registrar 
TMS 
Theatre Management System 
T&O 
Trauma & Orthopaedic 
THR 
Total Hip Replacement 
TSC 
Training & Standards Committee 
UTH 
University Teaching Hospital 
WGH 
Wycombe General Hospital 
WHO 
World Health Organisation 
W/L 
Waiting Lists 
 
5. BACKGROUND AND RATIONALE 
 
THR is one of the most commonly performed, cost-effective, and successful orthopaedic operations of the 
21st century. Since 2002, the NJR of England and Wales has recorded information on all patients and 

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implants used in arthroplasty (joint replacement) surgery, including THR, and report these figures annually 
(http://www.njrcentre.org.uk). According to the 15th annual NJR report in 2018, 91,698 primary (first time) 
THR’s were performed in the year up to 31st December 2017. Furthermore, a total of 992,218 primary THR 
have been recorded on the NJR following its inception in 2002, which reflects the huge demand for this 
operation. According to the latest NJR annual report data, the mean age for a patient undergoing a primary 
THR is 68.0 (SD 11.4), with 59.8% females and 40.2% males. The most common indication for a patient to 
have a THR in the NHS is primary osteoarthritis of the hip joint, which accounted for 90% (n=86,994) of all 
THR cases recorded in the 15th annual NJR report. 
 
This study builds upon previous research from our group, which has demonstrated the value of simulation 
training in arthroscopic orthopaedic surgery, and mini-open partial (uni-compartmental) knee 
replacement. This research proposal aims to utilise similar proven methodology and validated technology 
to evaluate and determine the effectiveness of simulation training in THR surgery, with the aim of 
improving training and patient outcomes. Defining an ‘expert’ surgeon standard in primary THR has never 
been attempted using motion analysis data. However, previous research from our group has used this 
technology and methodology to differentiate surgeons of various levels of training based upon their intra-
operative performance metrics as measured by the wireless motion sensors. The accuracy, validity, and 
safety of these motion sensors has been proven in these previous research projects, and we now plan on 
utilising them in a commonly performed ‘open’ orthopaedic operation. 
The reasons for undertaking this study are to improve training in THR surgery, and to make 
recommendations to the national orthopaedic training and standards committee. By delivering the above 
aims, we will be able to:  
1) Determine if additional simulation-based training for surgical trainees leads to improved intra-
operative performance, or patient outcomes following THR. 
2) Define an expert standard when performing a primary elective THR. This information will be a 
useful ‘benchmark’ against which Surgical Trainees performance and competence can be 
measured. 
3) Determine if operative surgeon performance metrics during a THR relate to surgical experience, 
or patient outcomes. 
 
The justification for including an ‘Expert’ comparator group within our study is to establish a benchmark 
standard of the optimal surgical performance metrics for a primary THR, against which we can assess StR 
performance. Within this study we have combined the ‘Experts’ and ‘Fellows’ into a single group as all the 
participants within this group are post-CCT (certificate of completion of training) in Trauma & Orthopaedic 
Surgery, and will undertake the same assessments at the same time points. The ‘Fellows’ are eligible to 
apply for Consultant posts, and will therefore represent a sub-Consultant level of performance, which we 
anticipate to be higher than that of StR’s, but potentially below that of an established Consultant. The 
reason we are recording performance data for both ‘Experts’ and ‘Fellows’, is that this will allow further 
sub-group analysis, which may identify differences in performance metrics or patient outcomes between 
these surgeons. 
 
The simulation-based training (intervention) to be tested in this study has been granted ethical approval 
by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (Reference MS-
IDREC R57808/RE001).  
6. OBJECTIVES AND OUTCOME MEASURES 

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Objectives 
Outcome Measures  
Timepoints of evaluation  
Primary 
 
To assess the impact of 
simulation training on surgical 
trainee performance and 
patient outcomes following 
THR. 
Participants: 
• 
Wireless motion data metrics from 
elbow worn sensors (hand 
movements, path length and time 
taken) 
• 
Global Rating Scales (GRS). 
• 
Objective Structured Assessment 
of Technical Skills (OSATS). 
• 
Surgical checklists. 
 
Patients: 
• 
X-ray analysis of THR.[4]  
• 
Blood loss and transfusion rates. 
• 
Peri-operative patient morbidity 
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
Intra-operative assessments 
to be performed at a 
minimum of 8 separate THR 
operations for each 
participant in Group 1 
(StR’S) over a 6-month 
period. 
 
 
Outcome measures data 
will be collected for all 
patients who have had a 
THR performed by any 
participant as the lead 
surgeon in this study. 
Secondary 
 
To define an expert standard 
when performing a primary 
elective THR. 
 
To determine if operative 
surgeon performance metrics 
during a THR relate to surgical 
experience, or patient 
outcomes. 
Participants: 
• 
Wireless motion data metrics from 
elbow worn sensors (hand 
movements, path length and time 
taken) 
Patients: 
• 
X-ray analysis of THR.[4]  
• 
Blood loss and transfusion rates. 
• 
Peri-operative patient morbidity  
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
Intra-operative assessments 
at a minimum of 5 separate 
THR operations for each 
participant in Group 2 
(Experts & Fellows). 
 
Outcome measures data 
will be collected for all 
patients who have had a 
THR performed by any 
participant as the lead 
surgeon. 
 
7. STUDY DESIGN 
Please see Appendix A for study flow diagram. 
 
This is a prospective randomised controlled study designed to assess the impact of specific training 
interventions on surgical trainee’s operative performance and patient outcomes following primary elective 
THR. We will also study the performance and patient outcomes of both ‘Experts’ and ‘Fellows’ in an 
additional comparator group, which will allow a potential expert standard in THR to be defined. 
 
All study participants will be recruited from 2 Hospitals within the Thames Valley (Oxford) Post-graduate 
Medical Deanery, and will be composed of: Trauma & Orthopaedic Specialty Registrars (‘StRs’) holding 
national training numbers; Consultant Orthopaedic Surgeons (‘Experts’); and Orthopaedic Arthroplasty 
Fellows (‘Fellows’). Over the 18-24 month anticipated study period we aim on recruiting a total of up to 16 
StR’s, 8 Fellows, and 5 Experts. See section 9 for further details on participant recruitment. 

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StR’s will be randomised in a 1:1 ratio to receive either: routine normal Deanery training (the control group, 
n=8); or routine normal Deanery training with additional simulation-based and cognitive learning (the 
intervention group, n=8). The intervention group will receive this training for 1-2 hours per week over a 4 
to 6-week period. The ‘Experts’ and ‘Fellows’ will not be eligible for any intervention, and will act as a 
separate comparator group.  
 
All participants will be assessed intra-operatively at set timepoints when performing elective primary THR 
surgery on patients within the named NHS Hospitals. The timepoints will vary depending upon each group. 
Each StR enrolled into this study will be assessed at a minimum of 8 separate THR operations over a 6-
month period, commencing at 6 weeks in to their 6-month clinical placement. Both the ‘Fellows’ and 
‘Experts’ will be assessed at a minimum of 5 separate THR operations depending upon the reliability of 
their performance data. 
 
All patients in this study will have been listed for routine elective primary THR surgery under a named 
Orthopaedic Consultant on the NHS. There will be no interventions or deviations from routine clinical 
practise regarding the pre-operative investigations or work-up, the operation itself, the peri-operative 
care, or post-discharge follow-up. 
8. PARTICIPANT & PATIENT IDENTIFICATION 
 
8.1. Consultants, Fellows, and Specialty Registrars 
 
Group 1 (‘StR’s’): Trauma & Orthopaedic Specialty Registrars on Arthroplasty clinical placements. 
Group 2 (‘Experts’ and ‘Fellows’): Consultant Orthopaedic Surgeons, and nationally appointed Orthopaedic 
Arthroplasty Fellows. 
Inclusion Criteria 
 
Group 1 (‘StR’s’): All Specialty Registrars holding a National Training Numbers (NTN) in Trauma & 
Orthopaedic Surgery within the Thames Valley (Oxford) Deanery and who are or will be working on 
arthroplasty clinical placements at either the NOC, Oxford University Hospitals NHS Foundation Trust, or 
WGH, Buckinghamshire Healthcare NHS Trust over the specified recruitment period will be eligible for 
participation in this study. We anticipate recruiting 2 StR’s from each recruitment centre every 6 months, 
over an 18 to 24-month period (total n = 12-16).  
 
 
Group 2 (‘Experts’ and ‘Fellows’): All Consultant Orthopaedic Surgeons with a sub-specialty practise in 
adult reconstructive (arthroplasty) surgery holding substantive posts at the NOC are eligible for 
participation in this study. The Consultant Orthopaedic Surgeons at WGH will not be required for the intra-
operative assessment within this study, as we will gather sufficient motion data from the NOC Consultants 
to be able to benchmark an ‘expert’ performance. Nationally appointed Orthopaedic AF’s working at either 
at either the NOC, Oxford University Hospitals NHS Foundation Trust, or WGH, Buckinghamshire 
Healthcare NHS Trust over the specified recruitment period will be eligible for participation in this study. 
We anticipate recruiting 2 AF’s every 6-months over an 18 to 24-month period (total n = 6-8)  
Exclusion Criteria 
• 
Inability to comply with study procedures or timetable  

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• 
Moving outside of the area, relinquishing their position, or National Training Number. 
 
 
 
8.2. Patients 
 
Adult patients (aged 18 years or above) diagnosed with primary hip osteoarthritis who have been listed 
for elective primary THR in the NHS. 
Inclusion Criteria 
• 
Adult patients (aged 18 years or above) diagnosed with primary hip osteoarthritis who have been 
listed for elective primary THR in the NHS. 
• 
THR operation performed by a surgeon participant as lead surgeon. 
Exclusion Criteria 
Patients may not enter the study if ANY of the following apply: 
• 
Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection). 
• 
Patients who have had previous surgery on their affected hip. 
9. PROTOCOL PROCEDURES  
9.1. Recruitment  
 
9.1.1 Consultant, Fellow and Specialty Registrar recruitment 
 
Group 1: Specialty Registrars (‘StR’s’). 
StR’s will be identified within the Oxford Deanery’s T&O Higher Surgical Training Programme. The current 
Training Programme Director (TPD), Miss Jane Webber (Consultant Orthopaedic Surgeon at Milton Keynes 
University Hospital) has overall responsibility for allocating clinical placements to StR’s. With the 
agreement and assistance of the TPD, we will identify the StR’s who have been allocated clinical 
placements within the named recruitment centres over the upcoming 18 to 24-month recruitment period 
starting from September 2019, and contact them directly via e-mail to ask if they would be interested in 
participating in this study. There is a regional T&O StR group e-mail list, which will be used to inform all 
StR’s of this study. Furthermore, the lead researcher will attend the weekly T&O StR Teaching Programme 
in advance of the start of this study to hand out PIS in person, and any questions can be directly addressed. 
 
Group 2: Consultant Orthopaedic Surgeons (‘Experts’), and nationally appointed Orthopaedic Arthroplasty 
Fellows (‘Fellows’). 
The Experts and Fellows at the NOC and WGH will be approached in person to ask if they would be 
interested in participating in this study. A PIS outlining the study, including their role, will be provided for 
their attention, and any questions can be directly addressed. 
 
9.1.2 
Patient Recruitment 
 
Following screening and identification of patients using waiting lists within the Orthopaedic Department 
at the 2 named NHS Hospitals, the PI (DJH), or a suitably qualified deputy, will attend the patient’s routine 

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POAC appointment in order to highlight with the direct clinical care team that the patient may be eligible 
for participation in this study. The patients direct clinical care team will then approach the patient to 
enquire about participation in this study, and only if interest to participate is expressed, they will then be 
referred onto the PI. The PI will then proceed to confirm eligibility, and outline the purpose of the study. 
A patient information sheet and verbal information will be provided on: what data we will be collecting 
and specifically how it will be used; and any risks and benefits to taking part.  
9.2. Informed Consent 
The PI (DJH), or a suitably qualified deputy, will take informed consent from every participant involved in 
this study. This will be taken at their visit before any study specific procedures are performed.  
 
Each participant must personally sign and date the latest approved version of the Informed Consent form 
at this visit. Written and verbal versions of the PIS and Informed Consent form (ICF) will be presented to 
the participants detailing no less than: the exact nature of the study; what it will involve for the participant; 
the implications and constraints of the protocol; 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, 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 
in order 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. A copy of the signed Informed Consent will be offered to the participant. 
The original signed form will be retained by the PI (DJH) at the study site 
 
Visit 1 - Group 1 (‘StR’s’): 
 
Following enrolment for participation in this study, the StR’s will be randomly allocated to receive either 
routine normal Deanery training (the ‘control’ group), or routine normal Deanery training plus additional 
simulation training (the ‘intervention’ group). Following randomisation all StR participants will undergo a 
baseline written and practical skills assessment within the OOSEC. 
9.3. Subsequent Visits  
 
Group 1a (‘StR’s’) - Intervention group: 
StR’s randomised to the ‘intervention group’ will be required to complete the 4-week period of additional 
training outlined in section 9.3. Following completion of this additional training, participants within this 
group will undertake approximately 2 intra-operative assessments every 6 weeks over the duration of their 
6-month clinical placements (total 8 assessments). The StR’s will also undertake a final Technical Skills 
assessment in OOSEC Laboratory at 3 months into their placement (See Appendix A for Study Flow 
Diagram).  
 
Group 1b (‘StR’s’) – control group: 
 
Participants within this group will undertake approximately 2 intra-operative assessments every 6 weeks 
over the duration of their 6-month clinical placements (total 8 assessments). The StR’s will also undertake 
a final Technical Skills assessment in OOSEC Laboratory at 3 months into their placement (See Appendix A 
for Study Flow Diagram).  
 
Group 2: ‘Experts’ and ‘Fellows’: 

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Following enrolment for participation in this study, all participants within this group will undergo a baseline 
practical skills assessment within the OOSEC. Participants within this group will then undertake a minimum 
of 5 separate intra-operative assessments each. 
 
Patients: 
Following enrolment for participation in this study, all patients will be asked to complete the pre-operative 
PROMs questionnaires (EQ-5D and OHS). These are part of routine clinical care, and are a mandatory for 
all patients undergoing THR in the NHS. The patients will not be asked to undertake any further 
assessments outside of their routine clinical care until the time of their scheduled post-operative out-
patient department (OPD) clinic review appointment. All patients will only be followed up routinely 
following discharge by their named Consultant in an OPD clinic. This OPD appointment normally takes 
place 6 to 8 weeks following discharge. No additional clinic appointments or investigations will be required 
outside of the patients expected routine clinical care. At this visit the patients will be asked to complete 
the post-operative validated PROMs questionnaires (EQ-5D and OHS). This takes a few minutes and is the 
only extra outcome measure the patients are asked to complete. 
 
9.4 Randomisation 
 
Randomisation will be performed via a blinded sealed envelope containing information regarding which 
arm of the study they will participate in. As we only anticipate recruiting 2 StR’s from each recruitment 
centre every 6 months, a more complex allocation/randomisation procedure will not be required. Over 
the 18 to 24-month study period we aim to recruit and randomise 6-8 StR’s to the ‘intervention’ group, 
and randomise 6-8 StR’s to the ‘control’ (routine training) group, with an even distribution of these StR’s 
in both groups across the two recruiting hospital sites. 
9.5 Blinding and code-breaking  
 
Standard surgical practise will be followed. Patients are not formally blinded to which Surgeon (Consultant, 
Fellow, or StR) performs their operation, and are informed if requested. In line with standard surgical 
practise and training within the NHS, patients will provide informed consent that they understand no 
guarantees can be given that a particular person will perform the procedure. The person will, however, 
have appropriate experience. 
 
Due to the nature of this study the StR’s cannot be blinded to their allocations into either the ‘control’ or 
‘intervention’ groups, however the assessment methods and any assessors will be blinded. 
9.6 Description of study intervention(s),  
 
The intervention to be tested is the simulation-based and cognitive learning package, which will be 
delivered to a randomised sub-group of 50% of the StR’s recruited into this study. This will be delivered in 
a supervised setting within the OOSEC over a 4-week period for between 1 to 2 hours per week, over 3 to 
4 consecutive but separate six-month placements (please see Appendix A for Study Flow Diagram). This 
will take place on a Wednesday afternoon, which is when all the Regional StR’s are due to attend teaching 
in Oxford at the NOC. 
 
The OOSEC is a secure enclosed laboratory space within the NOC, which contains all the necessary 
equipment required to run the simulation-based and cognitive learning training. The simulation training in 
general may include: 

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1) Focussed workshops on saw-bone models (simulated bones) 
2) Digital and computer-based cognitive learning packages 
3) Virtual reality platforms.  
 
All participants within group 1 (StR’s) will be asked to attend and complete baseline and final assessments 
within the OOSEC, which will consist of a multiple-choice questionnaire (MCQ) and a simulated procedure. 
Participants within group 2 (Consultants and Fellows) will only be required to complete a baseline 
simulated procedure. 
9.7 Intra-operative surgeon performance data collection  
 
The following protocol will apply to all episodes of intra-operative performance data collection for StR’s 
and Fellows. The intra-operative data collection for Consultant performed operations will differ slightly in 
that they require no supervision, and no surgeon will ‘take over’ the operation. However, the methods for 
recording the intra-operative data will remain the same. 
A maximum of two study participants (excluding Consultants) will attend any given list. The PI (DJH) will 
attend the World Health Organisation (WHO) briefing in theatre on the morning of the list, introduce 
themselves and explain their role during the list. If recording an StR, neither the participant or PI will 
disclose which arm of the study the participants are in (routine training, or additional simulation training). 
The supervising Consultant will confirm the cases on the list the StR or AF’s will be performing under 
supervision and training. 
Operative protocol 
After anaesthesia and patient set-up, the supervising Consultant and participant will scrub in up in the 
usual manner with the motion sensors in position on the lead surgeon’s elbows under their sterile gown 
(see Appendix C). The procedure will then continue routinely and normally, but with the PI collecting 
motion data via the wireless Bluetooth sensors. The PI will also manually record the timings of each stage 
of the THR operation. This process will allow synchronisation of motion data to the participants 
progression throughout the stages of the operation. Data collection will stop when the dressing has been 
applied to the surgical wound.  
Following completion of the operation, the participants in conjunction with the supervising Consultant will 
be asked to complete short written assessments of the lead surgeons’ intra-operative performance. These 
assessments may include: Global Rating Scales (GRS), Objective Structured Assessment of Technical Skills 
(OSATS), and surgical checklists. 
Intra-operative deviations or interruptions 
Sometimes the supervising Consultant needs to take over part or all of an operation if it proves particularly 
difficult. In the event that a procedure has to be taken over completely by the Consultant then data 
recording will stop. If minor adjustments only are made by the Consultant during the operation then these 
will be noted and time marked against the motion data.  
9.8 Protocol Early Discontinuation/Withdrawal of Participants 
 

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During the course of this study a participant or patient may choose to voluntarily withdraw early at any 
time. This may happen for several reasons, including but not limited to: 
• 
Inability to comply with study procedures or timetable. 
• 
Participant or patient decision. 
• 
Moving outside of the area. 
 
Patients or participants may choose to stop study assessments. Patients or participants may also withdraw 
their consent, meaning that they wish to withdraw from the study completely. Patients who withdraw 
from this study will continue to receive routine clinical care under their named Consultant on the NHS. 
 
According to the design of the study, the Investigator may discontinue a patient or participant from the 
study treatment at any time if the Investigator considers it necessary for any reason including, but not 
limited to: 
• 
Ineligibility (either arising during the study or retrospectively having been overlooked at 
screening). 
• 
Significant protocol deviation. 
• 
Significant non-compliance with intervention (simulation training) or study requirements. 
• 
Clinical care decision.  
9.9 Definition of End of Study 
 
The end of study will be the date of the last visit of the last patient at follow-up, at which point all of the 
study data has been entered and queries resolved. We anticipate that this will be by December 2021. 
10 SAFETY REPORTING  
 
Patients will not be placed at any additional risk during this study. 
 
The participants in the ‘simulation-training sub-group’ of this study will be expected to participate in low-
risk simulated surgical activities within the OOSEC. The low risk to participants will also be highlighted as 
part of the informed consent process, which will take place before any study-specific procedures or 
training are performed. Such activities will be those normally encountered in their training, such as the 
use of orthopaedic power tools, saws, and sharp instruments. As part of the baseline visit, the lead 
investigator, or suitably qualified deputy, will outline the materials and tasks involved in each training 
session to the participants. The training sessions will be delivered in a supervised setting to StR's within 
the OOSEC, which is part of the University of Oxfords premises (NDORMs). As specified previously the 
OOSEC is a secure enclosed laboratory space, which contains all the necessary equipment required to run 
the simulation-based and cognitive learning training.  
 
In the unlikely event that any participant sustains an injury, we will follow the OOSEC safety policy. Any 
significant incidents will be recorded in a logbook within the OOSEC, and reported directly to the Health & 
Safety Manager within the Medical Sciences Division of the University of Oxford. 
10.4 Definition of Serious Adverse Events 
 
A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening 
• 
requires inpatient hospitalisation or prolongation of existing hospitalisation 

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• 
results in persistent or significant disability/incapacity 
• 
consists of a congenital anomaly or birth defect. 
As outlined in section 10 above, we do not anticipate any serious adverse events whilst conducting our 
intervention simulation training. In the extra-ordinary event that any were to occur we would follow the 
OOSEC Health & Safety Policy. 
This study does not add any additions to the usual inherent risks associated with THR surgery. If any patient 
were to experience a serious adverse event during the operation, peri- or post-operative period, these 
would be as a consequence of their normal care, and not this study. These would therefore be investigated 
in line with NHS protocols. We will also report on patient’s peri-operative morbidity (30 day) as part of the 
secondary objectives outlined in section 6 of this study. 
10.5 Reporting Procedures for Serious Adverse Events 
 
A serious adverse event occurring to a participant will be reported to the REC that gave a favourable 
opinion of the study where in the opinion of the Chief Investigator the event was ‘related’ (resulted from 
administration of any of the research procedures), and ‘unexpected’ in relation to those procedures. 
Reports of related and unexpected SAEs will be submitted within 15 working days of the Chief Investigator 
becoming aware of the event, using the HRA report of serious adverse event form (see HRA website). 
11 STATISTICS AND ANALYSIS 
 
Analysis of motion data.  
Motion data from the wireless sensors produces performance surrogate markers such as: the number of 
movements (major & minor); total path length; and smoothness/economy of movement. Data 
distributions will be assessed for normality using the Shapiro-Wilk test. Previous studies show such data 
are not normally distributed, and we would expect to use non-parametric tests, such as the Mann-Whitney 
U test to compare the performance metrics between the 2 groups of participants (StR’s against Experts & 
Fellows). The Mann-Whitney U test will also be used to compare performance metrics between the two 
sub-groups of StR’s (control and intervention), and also within the intervention sub-group in order to 
compare performance before and after training.  
 
Performance metrics within all groups of participants will be reported using descriptive statistics to outline 
the central tendency (mean, median, and mode) and variation (range, variance, and standard deviation) 
in readings obtained. The Kruskal-Wallis one-way analysis of variance (ANOVA) test will be used to test for 
differences in the mean values obtained for all performance metrics between the two groups of 
participants. The Wilcoxon signed-rank test will be used to determine any differences in performance 
metric between the two groups. 
 
Analysis of other routinely obtained data 
X-ray (radiograph) analysis: 
X-rays will be reviewed by two independent Consultant Orthopaedic Surgeons who will be blinded to the 
patient and lead surgeon’s identity in order to reduce bias. There are several important parameters to be 
evaluated when reviewing a pelvic x-ray, therefore we will ask each reviewer to allocate a categorical 
global rating (see below) for both the pre- and post-operative x-rays. [5] The Chi-squared test will be used 

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to determine if there are any significant differences between each group, and also intra-group differences 
(for example StR’s before and after additional training). 
 
Pre-operative x-ray 
1: Hip osteoarthritis without significant bone loss. 
2a: Hip osteoarthritis with significant bone loss on acetabular side. 
2b: Hip osteoarthritis with significant bone loss on femoral side. 
3: Hip osteoarthritis with significant bone loss on both acetabular and femoral sides. 
 
Post-operative x-ray 
1: Excellent implant position and restoration of hip anatomy. 
2a): Good overall with minor imperfections on acetabular side. 
2b): Good overall with minor imperfections on femoral side. 
3: Moderate concerns but does not require revision surgery. 
4: Significant concerns requiring revision surgery. 
 
Every patients post-operative x-ray will also be reviewed by the PI (DJH) for acetabular component 
positioning (inclination and version) using the methodology described by Bachhal [4]. This continuous data 
will be assessed for normality of distribution, and analysed using similar methodology as described above 
for the motion data. We will be looking for any statistically significant differences between the 2 groups of 
participants, within the two sub-groups of StR’s (control and intervention), and also within the intervention 
sub-group in order to compare performance before and after additional training.   
 
Other outcomes data: 
Following collection of the outcome measures listed below, the normality of the data distribution will be 
checked with the Shapiro-Wilk test. Descriptive statistics will be used to outline the central tendency and 
variation of these data sets. Statistical analyses between each group of participants will be performed 
using either the parametric unpaired t-test or a non-parametric Mann-Whitney U test depending on the 
distribution of the data. Subsequent analysis of the outcomes data using a paired t-test, or Mann-Whitney 
U test will also be performed within the two sub-groups of the StR’s (control and intervention), and also 
within the intervention sub-group in order to compare outcomes before and after additional training.   
 
• 
Theatre time usage. 
• 
Blood loss (pre-/post-op haemoglobin levels) 
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
 
The Chi-squared test (or Fishers exact test if the sample is <5) will be used to determine any significant 
differences between the groups regarding the incidence of blood transfusions or peri-operative morbidity. 
 
All of these tests will be performed using the SPSS statistical package, which is available for any registered 
student on the University of Oxford current Licencing agreement. 
12 DATA MANAGEMENT 
 
 
Within this study both patients and participants will have all of their personal data anonymised via the use 
of Unique Patient or Participant Identifiers (UPI’s). A master list of key linking identifiers for both patients 

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and participants will be kept on a password protected file on the OUH secure Trust Network Server. Only 
completely anonymised data will be used outside of OUH Trust property, which will be kept on a password-
protected University owned laptop or hard-drive. We plan on keeping study data for a period of 5 years 
following completion on the study (up to December 2026), before securely disposing of it. We believe that 
this storage is appropriate as the core content is scientific research data and is therefore in the public 
interest. Furthermore, we will require access to this data in the case of individuals wishing to scrutinise 
the scientific methodology, results, or conclusions of our study.  
 
Intra-Operative Data 
Raw data will be produced from the wireless sensors. Please see section 12.3 for further details regarding 
the recording, transfer, and storage of this data. 
 
Other ‘personal data’ 
 
1) Electronic Patient Record Data 
The following data will be obtained from the NHS Electronic Patient Records (EPR), which includes the 
Insignia Picture Archiving and Communication System (PACS), and the Theatre Management System 
(TMS):  
• 
X-ray (radiograph) analysis. 
• 
Theatre time usage. 
• 
Blood test & transfusion rate analysis. 
• 
Peri-operative morbidity (30 day). 
• 
In-patient length of stay. 
• 
Patient demographics (age, gender, BMI) 
 
2) Questionnaire Data 
 
Patient Questionnaire Data 
The patient questionnaires consist of the following components: 
- 
Patient Reported Outcome Measures: The OHS and EQ-5D.  
 
Participant (Medical Health Professionals) Questionnaire Data 
Written assessments of intra-operative performance will be conducted shortly after completion of a 
recorded THR. These assessments may include: Global Rating Scales (GRS), Objective Structured 
Assessment of Technical Skills (OSATS), and surgical checklists. The data collected from these will be 
anonymised as it will be linked with the UPI, and not provide any names or other personal information. 
The hard copies will be transcribed into digital format as soon as possible, which will be stored onto a 
password protected encrypted file on a University owned computer/hard-drive. The hard copies of the 
forms will then be disposed of. 
12.4 Source Data 
 
Please see section 12 on Data management for further details. In general, the source data is as follows: 
 
Intra-Operative Data 
• 
Wireless motion data. 
• 
Global rating scales and checklists. 
 
Hospital Records Data 
• 
NHS EPR for laboratory and clinical data. 

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• 
Insignia PACS for radiograph (x-ray) analysis. 
• 
TMS for theatre lists, workflow, and productivity information. 
 
Questionnaire Data 
• 
PROMs questionnaire forms to be completed pre- and post-op (as detailed above). 
• 
Participant performance assessment tools and feedback forms. 
 
All confidential data will be stored securely. On all study-specific documents, other than the signed 
consent, the participant and patients will be referred to by the study UPI, and not by name. 
12.5 Access to Data 
 
OOSEC research team members will have access to the raw motion data. This can be matched to other 
metrics during the THR surgery through the use of Unique Participant Identifiers (UPI).  
 
Direct access to the data generated from this study will be granted to authorised representatives (for 
example the Data Protection Officer, Caldicott Guardian, or Information Governance Team) from the 
sponsor and host institution for monitoring and/or audit of the study to ensure compliance with 
regulations. 
12.6 Data Recording and Record Keeping 
 
Intra-operative data 
 
Motion Data 
Anonymised non-personal raw motion data from the motion sensors will be wirelessly 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 internet. The data centres are staffed 24x7 by trained security guards and access is 
authorised strictly on a least privileged basis. Usable output motion analysis metrics will be downloaded 
from the secure server and stored locally on an Excel spreadsheet (.xlsx) or similar software. 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 
or similar. 
 
Electronic Patient Record Data 
The routine patient data will be accessed via their unique Hospital/NHS number on the recruiting NHS 
Trusts computer system. Following identification, the minimum dataset required (outlined previously) will 
be extracted by manually transcribing it directly onto a password protected encrypted file on a University 
owned computer/hard-drive. The data within this file will be anonymised using the UPI, and cannot be 
linked to any patient directly. No patient identifiable data will be directly transferred or saved from the 
recruiting NHS Trusts computer system. 
 
Patient & Participant Questionnaire Data 
Data from the hard copies of each questionnaire (detailed above) will be transcribed into digital format as 
soon as possible, which will be stored onto a password protected encrypted file on a University owned 
computer/hard-drive. The hard copies of the forms will then be disposed of. As they will not contain any 
personal data they will not have to be securely disposed of (confidential waste bins/shredding). 

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13 QUALITY ASSURANCE PROCEDURES 
 
The study may be monitored, or audited in accordance with the current approved protocol, GCP, relevant 
regulations and standard operating procedures.  
13.4 Risk assessment  
 
Please see section 10 on safety reporting. 
13.5 Study monitoring  
 
Not applicable. 
13.6 Study Committees  
 
There will be no oversight committees for this study.  
14 PROTOCOL DEVIATIONS  
 
A study related deviation is a departure from the ethically approved study protocol or other study 
document or process (e.g. consent process or administration of study intervention) or from Good Clinical 
Practice (GCP) or any applicable regulatory requirements. Any deviations from the protocol will be 
documented in a protocol deviation form and filed in the study master file.  
15 SERIOUS BREACHES 
 
A “serious breach” is a breach of the protocol or of the conditions or principles of Good Clinical Practice 
which is likely to affect to a significant degree – 
 (a) the safety or physical or mental integrity of the trial subjects; or 
(b) the scientific value of the research. 
 
In the event that a serious breach is suspected the Sponsor must be contacted within 1 working day. In 
collaboration with the C.I., the serious breach will be reviewed by the Sponsor and, if appropriate, the 
Sponsor will report it to the approving REC committee and the relevant NHS host organisation within seven 
calendar days.  
16 ETHICAL AND REGULATORY CONSIDERATIONS 
16.4 Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
16.5 Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 

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16.6 Approvals 
 
Following Sponsor approval, the protocol, informed consent form, and participant information sheet will 
be submitted to an appropriate Research Ethics Committee (REC), and HRA (where required) and host 
institutions for written approval. 
 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
16.7 Other Ethical Considerations 
 
One potential ethical consideration in relation to this study will be what the researcher should do if a senior 
participant (Consultant or Fellow) is found to be underperforming in comparison to their peers. After much 
consideration, and consultation with the University of Oxfords Medical Sciences Interdivisional Research 
Ethics Committee (MS-IDREC), we have adopted the following approach to this situation, however we 
would welcome any additional advice or guidance from the NHS REC: 'The data generated within this study 
will be anonymised using Unique Participant Identifiers (UPI's), and all participants will be exempt from 
individual disclosure or reporting of their study data to regulatory bodies (such as the Joint Committee on 
Surgical Training (JCST), Royal Colleges of Surgeons (RCS), or General Medical Council (GMC). It is not the 
purpose or role of this study to assess the clinical competence of surgeons, as this is undertaken through 
a prolonged and rigorous series of post-graduate professional assessments and examinations conducted 
by the above-named regulatory bodies. In the event of a senior colleague performing consistently and 
substantially below the level seen within their peer group, then this will be anonymously highlighted within 
the results section of the study report, which will be openly available for review. Furthermore, all 
participants will be individually informed of their performance results, which will be supplied in the context 
of their respective peer groups. It will be up to the professional judgement of the individual participant to 
reflect and decide how to act upon their results'.  
16.8 Reporting 
 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the REC 
Committee HRA (where required) host organisation, Sponsor and funder (where required). In addition, an 
End of Study notification and final report will be submitted to the same parties. Following completion of 
this study, all participants will be informed of the results of their individual performances, which will be 
anonymously reported in comparison to the average group level results of participants of other training 
levels. Patients will be offered the opportunity to be sent a newsletter containing the summary results 
following completion of this study. 
16.9 Participant Confidentiality 
 
The study will comply with the General Data Protection Regulation (GDPR) and Data Protection Act 2018, 
which require data to be de-identified as soon as it is practical to do so. The processing of the personal 
data of participants will be minimised by making use of a unique participant study number only on all study 
documents and any electronic database.  All documents will be stored securely and only accessible by 
study staff and authorised personnel. The study staff will safeguard the privacy of participants’ personal 
data. 
16.10 
Expenses and Benefits 
 

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No additional expenses will be made for either the patient’s or participants involvement in this study. 
 
The direct benefits to participants may include: 
• 
The opportunity to practice and develop their surgical skills under supervision in the simulation 
laboratory. 
• 
The opportunity to objectively assess their surgical skills using the wireless motion sensors, which 
may in turn highlight areas for improvement. 
• 
The opportunity to complete work-based assessments as part of the study (for example the PBA 
form), which are currently an integral part of surgical training requirements. 
17 FINANCE AND INSURANCE 
17.4 Funding 
This study is being kindly funded through a research grant from the Dinwoodie Charitable Company. 
17.5 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. 
17.6 Contractual arrangements  
Appropriate contractual arrangements will be put in place with all third parties.  
18 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 the 
Dinwoodie Charitable Company. Authorship will be determined in accordance with the ICMJE guidelines 
and other contributors will be acknowledged. 
19 DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF INTELLECTUAL PROPERTY  
 
Not applicable 
20 ARCHIVING 
The results of this study will form part of a Thesis submitted in support of an application for the Degree 
Doctor of Philosophy in Musculoskeletal Sciences (DPhil) by the PI (DJH) at the University of Oxford. 
21 REFERENCES 
 
1. 
Reiley, C.E., et al., Review of methods for objective surgical skill evaluation. Surg 
Endosc, 2011. 25(2): p. 356-66. 
2. 
Martin, J.A., et al., Objective structured assessment of technical skill (OSATS) for 
surgical residents. Br J Surg, 1997. 84(2): p. 273-8. 

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
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© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2018 
 
Page 24 of 28 
3. 
Garfjeld Roberts, P., et al., Objectively Assessing Intraoperative Arthroscopic Skills 
Performance and the Transfer of Simulation Training in Knee Arthroscopy: A 
Randomized Controlled Trial. Arthroscopy, 2019. 35(4): p. 1197-1209 e1. 
4. 
Bachhal, V., et al., A new method of measuring acetabular cup anteversion on simulated 
radiographs. Int Orthop, 2012. 36(9): p. 1813-8. 
5. 
Vanrusselt, J., et al., Postoperative radiograph of the hip arthroplasty: what the 
radiologist should know. Insights Imaging, 2015. 6(6): p. 591-600. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2018 
 
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22 APPENDIX A:  STUDY FLOW CHART 
 
 
 
Excluded 
  Declined to participate 
  Ineligible 
  Other reasons 
 Intra-op assessment every 6 weeks for 6 months, starting from   
     after completion of simulation training (total 8 assessments) 
 Wireless motion data, GRS, OSATS, checklists  
Intervention 
 4 Senior StR 
(ST6-8) @ NOC 
 4 Junior StR 
(ST3-6) @ WGH 
 Simulation 
Training 
 4 Senior StR 
(ST6-8) @ NOC 
 4 Junior StR 
(ST3-6) @ WGH 
Regular 
Training 
Final Assessment: 
Skills Lab & MCQ 
3 months post enrollment 
(Covered in CUREC) 
• 
X-ray analysis of THR.  
• 
Blood loss and transfusion rates. 
• 
Peri-operative morbidity 
• 
In-patient length of stay. 
• 
PROMs: EQ-5D and OHS. 
Randomisation
Group 2: ‘Experts’ and ‘Fellows’ 
Consultant Surgeons and Arthroplasty Fellows 
NOC: x5 Consultants, and x3-6 Fellows every 6 months 
WGH: x1 Fellow every 6 months 
Total n = 5 Experts; 8 Fellows 
Routinely collected patient outcome data  
Baseline Assessment: 
Skills Lab & MCQ 
(Covered in CUREC application: Reference MS-IDREC 
R57808/RE001) 
Group 1: ‘StR’s’ 
Specialty Registrars 
NOC: x2 StR every 6 months 
WGH: x2 StR every 6 months 
Total n = 16 StR’s 
 Intra-op assessment 
(minimum 5 assessments) 
 Wireless motion data  
Intra-operative data collection 
Patient 
Recruitment from 
POAC 
Screened from NHS 
waiting list 
Verbal information and 
PIS provided, and written 
informed consent 
bt i
d
Participant Recruitment 
Identified within Oxford Deanery and 2 named NHS 
Hospitals 
Verbal information and PIS provided, and written informed 

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2018 
 
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23 APPENDIX B:  SCHEDULE OF STUDY PROCEDURES FOR PATIENTS 
 
Procedures 
Routine Visits (3): pre-operative; in-patient; post-operative. 
NHS Waiting 
list review 
 
Pre-
operative 
clinic 
In-patient 
admission 
In-patient 
admission 
Out-
patient 
review 
Screening 
Baseline 
Intra-
operative 
Post-
operative 
In-patient 
6-8 weeks 
Post-
operative 
Out-
patient 
Informed consent 
 
✓ 
 
 
 
Demographics 
✓ 
 
 
 
 
Laboratory tests (Blood) 
 
✓ 
 
✓ 
 
Radiology 
 
✓ 
 
✓ 
 
Eligibility assessment 
✓ 
✓ 
 
 
 
Randomisation 
 
 
 
 
 
Electronic Patient Record Data 
 
✓ 
✓ 
✓ 
✓ 
Patient Questionnaire Data 
 
 
✓ 
 
 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2018 
 
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24 APPENDIX C:  Wireless Motion Sensors  
 
 
                
 
Wireless sensors 
 
 
 
 
 
Wireless sensors worn in theatre scrub room 
(Surgeon would put on sterile gown & 
gloves as standard prior to operation) 
 

Date and version No:     6th August 2019: Version 1.0 
 
 
Clinical Research Protocol Version 1.0: 6th August 2019 
 
 
 
 
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© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2018 
 
Page 28 of 28 
25 APPENDIX D:  AMENDMENT HISTORY 
 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made 
 
 
 
 
 
 
List details of all protocol amendments here whenever a new version of the protocol is produced.   
 
Protocol amendments must be submitted to the Sponsor for approval prior to submission to the REC 
committee and HRA (where required).