Evaluation of X-ray, Acetabular Guides and CT in THR
Phase: NA
Conditions: Total Hip Replacement
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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Evaluation of X-ray, Acetabular Guides and CT in THR 
Short Title: EXACT 
Trial Protocol 
ISRCTN Number 
Pending (reference: 33273) 
IRAS number 
218310 
Sponsor 
University Hospitals Coventry & Warwickshire NHS Trust 
Sponsor Reference 
RK174116 
Funding Body 
Corin Ltd, UK 
REC 
West Midlands – Solihull Research Ethics Committee 
REC Approval Date 
01.09.2017 
REC Reference 
17/WM/0261 
HRA Approval Date 
18.09.2017 
Version Number 
V2.3 
Date 
 28.05.2019 
 
Protocol Amendments: 
Amendment No. 
 
Date of Amendment 
 
Date of Approval 
1 
 
November 2017 
 
REC: 27.12.2017, R&D: 29.01.2018 
2 
 
March 2018 
 
REC: 16.04.2018, R&D: 17.04.2018 
2.1 
 
July 2018 
 
HRA: 17.07.2018, R&D: 26.07.2018 
2.2 
 
September 2018 
 
HRA: 02.10.2018, R&D: 18.10.2018 
3.1 
 
May 2019 
 
HRA: 21.06.2019, R&D: 21.06.2019 
 
 
 
 
 
 
 
 
 

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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Chief Investigator agrees to conduct the trial in compliance with the approved protocol and will 
adhere to the principles outlined in the Research Governance Framework, the ICH Good Clinical 
Practice guidelines and the Sponsor’s SOPs. 
 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the clinical investigation without the 
prior written consent of the sponsor.  
 
I also confirm that I will make the findings of the study publically available publications or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned from this 
protocol will be explained.  
 
 
For and on behalf of the study Sponsor: 
 
Signature: 
 
 
 
 
 
 
Date: 
 
……………………………………………………………  
 
 
………………………………………. 
 
Name (please print): 
 
…………………………………………………………… 
 
Position: 
 
…………………………………………………………… 
 
Chief Investigator: 
 
Signature: 
 
 
 
 
 
 
Date: 
 
……………………………………………………………  
 
 
………………………………………. 
 
Name (please print): 
 
………………………………………………………….. 
 
 
 
 
 
 
 

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CONTACT NAMES AND NUMBERS 
Role  
Name, address, telephone 
Sponsor: 
Mrs Ceri Jones 
Head of Research & Development 
4th Floor Rotunda 
University Hospitals Coventry & Warwickshire NHS Trust 
Clifford Bridge Road 
Coventry 
CV2 2DX 
 
Tel:  024 7696 6198 
Email:  ceri.jones@uhcw.nhs.uk  
 
Chief Investigator: 
 
 
 
 
 
Prof Richard King  
Consultant Orthopaedic Surgeon 
University Hospitals Coventry and Warwickshire NHS Trust  
Clifford Bridge Road 
Coventry 
CV2 2DX 
 
Tel: 02476 964209 
Tel: 02476 965065 (secretary) 
Bleep: 4265 
Mobile: 07545 151816 
Fax: 02476 965081 
Email: richard.king@uhcw.nhs.uk    
 
Co- Investigators 
Mr Andrew Metcalfe 
Associate Professor and Honorary Consultant 
University Hospitals Coventry and Warwickshire NHS Trust 
Tel: 02476 964965 (secretary) 
Mobile: 07809 564440 
Email: a.metcalfe@warwick.ac.uk  
 
Mr Pedro Foguet 
Orthopaedic Consultant  
University Hospitals Coventry and Warwickshire NHS Trust 
Tel: 02476 965065 (secretary) 
Bleep: 1811 
Email: pedro.foguet@uhcw.nhs.uk  
 
Peer review 
Internal Reviewer 
Mr John McArthur 
Consultant Orthopaedic Surgeon 
University Hospitals Coventry and Warwickshire NHS Trust  
Clifford Bridge Road 
Coventry 
CV2 2DX 
Tel: 024 76 965074  (secretary) 
Bleep: 4609 

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Fax: 02476 965081 
Email: john.mcarthur@uhcw.nhs.uk     
 
External Reviewer 
Mr David Woodnutt 
Consultant Orthopaedic Surgeon 
Morriston Hospital 
Heol Maes Eglwys 
Morriston, Swansea 
SA6 6NL  
Tel: 01792 702222 
Email: dave.woodnutt@gmail.com    
Patient Public 
Involvement 
Mr Patrick Carter 
Lay Member 
43 North Road 
Clifton on Dunsmore 
Rugby 
CV23 0BN 
 
Tel:01788 330154  
Email: p4tkd@sky.com  
Trial 
Management 
Group (TMG) 
Mrs Katie Bruce 
Trial Manager  
R&D, Trial Management Unit, 4th Floor, Rotunda 
University Hospital Coventry and Warwickshire NHS Trust 
Clifford Bridge Road 
Coventry 
CV2 2DX 
 
Tel: 02476966197 
Email: Katie.bruce@uhcw.nhs.uk 
 
 
Mr Shivam Joshi 
Study Support Assistant 
R&D, Trial Management Unit, 4th Floor, Rotunda 
University Hospital Coventry and Warwickshire NHS Trust 
Clifford Bridge Road 
Coventry 
CV2 2DX 
Tel: 02476 966907 
Email: Shivam.joshi@uhcw.nhs.uk  
 
Study email addresses:  
For patient enquiries:  Exactstudy@uhcw.nhs.uk  
For study management enquiries: ExactStudyOffice@uhcw.nhs.uk  
 

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Statistician 
Dr. Helen Parsons  
Warwick Clinical Trials Unit 
Warwick Medical School 
University of Warwick 
Coventry 
CV4 7AL 
 
Tel: 024 765 72665 (WCTU office) 
Email: h.parsons@warwick.ac.uk   
Randomisation 
Research & Development (R&D) Randomisation Unit 
4th Floor Rotunda 
University Hospitals Coventry & Warwickshire NHS Trust 
Clifford Bridge Road 
Coventry 
CV2 2DX 
 
Office hours: 9 am to 5 pm. 
Tel: 02476 966199 or 02476 967476  
Clinical queries   
Clinical queries and adverse events should be directed to Prof. Richard King 
or Mr. Foguet (contact details above). 
SAE reporting  
Serious Adverse advents to be reported to RD&Isponsorship@uhcw.nhs.uk 
Emergency 
Unblinding 
 
Office hours (9am to 5pm) ring 024 7696 4209 or 024 7696 5065  
Out of office hours -ring hospital switchboard on 02476 964000 and ask for 
Prof. Richard King or Mr. Foguet. 
Funder 
Corin Ltd  
Corinium Centre 
Cirencester 
Gloucestershire GL7 1YJ  
 
Tel: +44 (0)1285 659866 | Mobile: +44 (0)7970 109175 
Email: paul.gibbons@coringroup.com 
www.coringroup.com 
 
 
 
 
 
 

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1. 
TABLE OF CONTENTS 
 
 
1. 
TABLE OF CONTENTS ........................................................................................ 6 
2. 
STUDY SUMMARY .............................................................................................. 9 
3. 
LIST OF ABBREVIATIONS/GLOSSARY ......................................................... 11 
4. 
FIGURE 1 TRIAL FLOWCHART ....................................................................... 13 
5. 
TABLE 1: SCHEDULE OF EVENTS .................................................................. 14 
6. 
BACKGROUND ................................................................................................... 15 
 
Epidemiology and burden of the condition ........................................................... 15 
6.1
 
Existing knowledge ............................................................................................... 15 
6.2
 
Hypothesis ............................................................................................................. 15 
6.3
 
Need for a trial ....................................................................................................... 15 
6.4
 
Ethical considerations............................................................................................ 15 
6.5
 
Consort .................................................................................................................. 16 
6.6
 
Assessment and management of risk..................................................................... 16 
6.7
7. 
OBJECTIVES AND OUTCOME MEASURES ................................................... 16 
 
Primary objective .................................................................................................. 16 
7.1
 
Secondary objectives ............................................................................................. 16 
7.2
 
Primary Outcome Measure .................................................................................... 16 
7.3
 
Secondary Outcome Measure ................................................................................ 17 
7.4
8. 
TRIAL DESIGN.................................................................................................... 17 
 
Trial Summary ....................................................................................................... 17 
8.1
 
Trial Patients.......................................................................................................... 17 
8.2
 
Eligibility criteria .................................................................................................. 17 
8.3
8.3.1 
Inclusion criteria .................................................................................................... 17 
8.3.2 
Exclusion criteria ................................................................................................... 17 
 
Trial Groups .......................................................................................................... 18 
8.4
8.4.1 
Standard Group...................................................................................................... 18 
8.4.2 
Interventional Group ............................................................................................. 18 
 
Surgical Device ..................................................................................................... 19 
8.5
8.5.1 
Implant and device storage and implementation ................................................... 19 
9. 
TRIAL PROCEDURES & VISITS ....................................................................... 19 
 
Patient Identification ............................................................................................. 19 
9.1
9.1.1 
Informed Consent .................................................................................................. 19 
 
Visit 1- Baseline & Imaging .................................................................................. 20 
9.2
9.2.1 
Baseline observations ............................................................................................ 20 

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Imaging .................................................................................................................. 20 
9.3
 
Randomisation ....................................................................................................... 20 
9.4
 
Visit 2 – Surgery.................................................................................................... 20 
9.5
 
Visit 3- Follow Up (6 weeks ± 2 w) ...................................................................... 20 
9.6
 
Visit 4 – Follow Up (4 months ± 6w) ................................................................... 21 
9.7
 
Visit 5 – Follow Up (12 months ± 2m) ................................................................. 21 
9.8
10. 
BLINDING & UNBLINDING ............................................................................. 21 
 
Methods for ensuring blinding .............................................................................. 21 
10.1
 
Methods for unblinding the trial ............................................................................ 21 
10.2
11. 
TRIAL WITHDRAWALS .................................................................................... 22 
 
Post-randomisation withdrawals ........................................................................... 22 
11.1
 
Concomitant illness withdrawals........................................................................... 22 
11.2
 
Concomitant medication withdrawals ................................................................... 22 
11.3
 
Other withdrawals ................................................................................................. 22 
11.4
12. 
END OF TRIAL .................................................................................................... 22 
13. 
SAFETY MONITORING AND REPORTING .................................................... 22 
 
Definitions (from ISO/FDIS 14155) ..................................................................... 22 
13.1
13.1.1 
Adverse Device Effect (ADE) ............................................................................... 22 
13.1.2 
Adverse Event (AE) .............................................................................................. 23 
13.1.3 
Device deficiency .................................................................................................. 23 
13.1.4 
Investigational medical device .............................................................................. 23 
13.1.5 
Serious Adverse Device Effect (SADE) ............................................................... 23 
13.1.6 
Serious Adverse Event (SAE) ............................................................................... 23 
13.1.7 
Unanticipated Serious Adverse Device Effect (USADE) ..................................... 24 
 
Reporting procedures ............................................................................................ 24 
13.2
13.2.1 
Reporting of ADEs and AEs ................................................................................. 24 
13.2.2 
Reporting of SAEs/SADEs and USADEs ............................................................. 24 
14. 
TRIAL RESPONSIBILITES ................................................................................ 25 
 
Sponsor: ................................................................................................................. 25 
14.1
 
Chief Investigator: ................................................................................................. 25 
14.2
 
Trial Management Group (TMG): ........................................................................ 26 
14.3
15. 
DATA MANAGEMENT ...................................................................................... 26 
 
Data collection and management .......................................................................... 26 
15.1
 
Data storage ........................................................................................................... 26 
15.2
 
Data access and quality assurance ......................................................................... 26 
15.3
 
Archiving ............................................................................................................... 26 
15.4
16. 
STATISTICAL ANALYSIS ................................................................................. 26 
 
Power and sample size .......................................................................................... 26 
16.1

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Statistical analysis of efficacy and harms.............................................................. 27 
16.2
16.2.1 
Data analysis.......................................................................................................... 27 
16.2.2 
Planned recruitment rate ........................................................................................ 27 
17. 
TRIAL ORGANISATION AND OVERSIGHT ................................................... 27 
 
Sponsor and governance arrangements ................................................................. 27 
17.1
 
Regulatory authorities/ethical approval ................................................................. 27 
17.2
 
Trial Registration ................................................................................................... 28 
17.3
 
Notification of serious breaches to GCP and/or trial protocol .............................. 28 
17.4
 
Indemnity............................................................................................................... 28 
17.5
 
Trial timetable and milestones .............................................................................. 28 
17.6
 
Essential Documentation ....................................................................................... 28 
17.7
18. 
INTELLECTUAL PROPERTY ............................................................................ 29 
19. 
MONITORING, AUDIT AND INSPECTION ..................................................... 29 
20. 
PATIENT AND PUBLIC INVOLVMENT (PPI) ................................................ 29 
21. 
DISSEMINATION AND PUBLICATION .......................................................... 29 
22. 
REFERENCES ...................................................................................................... 29 
23. 
APPENDIX 1. ....................................................................................................... 31 
24. 
APPENDIX 2. ....................................................................................................... 39 
 
 
 
 
 
 
 
 
 
 
 
 

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2. 
STUDY SUMMARY 
FULL TITLE 
 
Evaluation of X-ray, Acetabular Guides and CT in Total Hip 
Replacement  
ACRONYM 
EXACT (Evaluation of X-ray, Acetabular Guides and CT in THR) 
CLINICAL PHASE 
Pilot Study  
HYPOTHESIS 
Acetabular alignment guide combined with three-dimensional 
CT-based planning using the Corin Optimized Positioning 
System will provide more accurate component alignment 
following primary total hip replacement compared with the 
current standard treatment 
TRIAL DESIGN 
Single-centre, 
patient-assessor 
blinded, 
parallel-group, 
randomised-controlled trial 
TRIAL POPULATION 
 
Patients aged 18-70 years with hip osteoarthritis undergoing 
total hip replacement with an uncemented acetabular cup 
PLANNED SAMPLE SIZE 54 
TREATMENT 
DURATION 
As the timescale of a standard hip replacement. Treatment 
duration will be unaffected by participation in the trial.  
FOLLOW UP 
6-weeks ( 2w), 4-months ( 6w)  and 12-months ( 2m) 
PLANNED TRIAL 
PERIOD 
The study will be last for 30 months and active recruitment 
will take place for 12 months. 
 TRIAL ARMS 
1:1 randomisation to: 
1) Standard Group– Standard care where hip replacement is 
planned using 2D X-ray templating software 
2) Interventional Group- where hip replacement is planned 
from 3D CT scan using Corin OPS™. Corin OPS™ acetabular 
guide provided for use during hip replacement. 
STUDY OUTCOME  
Objectives 
Outcome measures 
Primary  
 
Difference 
between 
planned and achieved 
acetabular component 
anteversion angle 
CT Scan 
 

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Secondary 
 
To quantify and draw 
inferences 
on 
the 
efficacy 
of 
the 
treatment groups using 
different measures and 
patient 
reported 
observed differences  
CT scan, HOOS, OHS, EQ-5D, 
adverse 
events 
and 
motion-
capture data. 
 
 
Keywords:  hip replacement, acetabulum, anteversion, position, guide 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. 
LIST OF ABBREVIATIONS/GLOSSARY  
Abbreviation  
Explanation 
2D  
Two Dimensional 
3D 
Three Dimensional 
AAOS 
American Academy of Orthopaedic Surgeons 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BHS 
British Hip Society 
BMI 
Body Mass Index 
BOA 
British Orthopaedic Association 
CI 
Chief Investigator 
CONSORT 
Consolidated Standards of Reporting Trials 
CORIN OPS™ 
CORIN Optimised Positioning System 
CRF 
Case Report Form 
CT 
Computed Tomography 
DVT 
Deep Vein Thrombosis 
EC 
European Commission 
EQ-5D 
EuroQol five dimensions questionnaire 
EudraCT 
European Clinical Trials Database 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
HOOS 
Hip Disability & Osteoarthritis Outcome Score 
HRA 
Health Research Authority 
IRAS 
Integrated Research Application System 
ISRCTN 
International Standard Randomised Controlled Trial Number 
MHRA 
Medicines and Healthcare products Regulatory Agency 
MRC 
Medical Research Council 
NHS 
National Health Service 
OHS 
Oxford Hip Score 
PE 
Pulmonary Embolism 
Post-Op 
Post-Operative 
PPI 
Patient & Public Involvement 
Pre-Op 
Pre-Operative 
R&D 
Research & Development 

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RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event  
SAP 
Statistical Analysis Plan 
SOP 
Standard Operating Procedure 
THR 
Total Hip Replacement 
TMG 
Trial Management Group 
UHCW 
University Hospitals Coventry and Warwickshire  
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4. 
FIGURE 1 TRIAL FLOWCHART 
 
 

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5. 
TABLE 1: SCHEDULE OF EVENTS 
Observations 
Pre-
eligibility* 
Baseline & 
Imaging 
 
Surgical admission 
Follow- up 
 
Pre-op 
Post-Op 
 (Time  Range)  
 
Visit 1* 
 
Visit 2 
0 weeks 
Visit 3 
6 weeks 
( 2w) 
Visit 4^ 
4 months 
( 6w) 
Visit 5 
12 months 
( 2m) 
Informed Verbal Consent 
X 
 
 
 
 
 
Patient Questionnaires (HOOS, 
EQ-5D, Oxford Hip Score) 
X 
 
- 
X 
X 
X 
Eligibility assessment 
X 
 
 
 
 
 
Demographics 
 
X 
- 
- 
- 
- 
Medical History 
 
X 
- 
- 
- 
- 
Current Medications 
 
X 
- 
- 
- 
- 
Clinical assessment  
 
X 
- 
X 
- 
- 
Motion capture (accelerometer)¥  
 
X 
- 
- 
- 
X 
X-Ray (AP pelvis,) 
 
X* 
X 
- 
- 
X 
X-Ray (x3 lateral spine) 
 
X* 
- 
- 
- 
X 
CT scan 
 
X* 
- 
X# 
- 
- 
Randomisation 
 
X 
- 
- 
- 
- 
Surgery 
 
- 
X 
- 
- 
- 
AEs/SAEs 
 
- 
X 
X 
X 
X 
End of Study 
 
- 
- 
- 
- 
X 
*Completed via telephone 
^Visit 4 follow up is not a clinic appointment. It will be completed via phone and post.  
#CT scan, where possible, will be arranged on the same day as visit 3. However, on occasions, a separate appointment may be provided pending availability of imaging facility at the Trust.¥ Motion 
capture will only be taken if the appropriate staff are available to do so. 

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6. 
BACKGROUND  
 
Epidemiology and burden of the condition 
6.1
Total hip replacement is one of the most successful surgical procedures of modern times, with over 80,000 performed each year in the 
UK1. The vast majority of patients experience dramatic pain relief and improvement in function for many years. Despite this, however, 
there remains a significant risk of complications, including dislocation, leg length discrepancy, squeaking, and premature wear and failure 
of the implant. It is known that such complications are more likely to occur if the acetabular component is incorrectly positioned during 
the surgery2–4. Up to 5% of all primary hip replacements need to be revised within the first 10 years1, and in many cases malposition of the 
acetabular (hip socket) component is implicated in the early failure.  
 
Existing knowledge 
6.2
Lewinnek defined a “safe zone” for positioning of the acetabular component, which, if achieved, should be associated with lower rates of 
complications5. The standard method of positioning the acetabular component is for the surgeon to be guided by a combination of the 
visible anatomical landmarks within the surgical field, and the wider environment of the operating theatre. For example, the surgeon will 
typically use their judgement to incline the acetabular component at 40° to the horizontal plane, as the patient lies on their side. This 
“freehand technique” is known to be prone to error, despite the added use of detailed surgical planning using CT scans6. 
The advent of 3D printing has led to the development of custom-made surgical guides which can be used during surgery, in order to assist 
the surgeon in the positioning of instruments and devices. These surgical guides are manufactured based on CT or MRI imaging, and are 
designed to clearly indicate to the surgeon the desired location and orientation of bony cuts and implant positions. This is now well 
established practice in knee replacement surgery, with evidence that it can led to improved accuracy of component positioning7,8. There 
have also been a small number of studies reporting improvements in acetabular component positioning during total hip replacement 
using custom acetabular guides 9–11. 
 
Hypothesis  
6.3
The primary hypothesis is that an acetabular alignment guide combined with three-dimensional CT-based planning using the Corin OPS™ 
(Optimised Positioning System), will provide more accurate component alignment following primary total hip replacement compared with 
the current standard treatment. 
 
Need for a trial 
6.4
The Corin OPS™ offers such a custom-made acetabular alignment guide12. Prior to the patient’s surgery, a CT scan of the patient’s pelvis & 
legs is performed, and the images are used to produce a 3D computer model of the patient as they stand with a “virtual” hip replacement 
in place. Three additional X-rays of the pelvis and lumbar spine are also taken, with the patient adopting various predetermined 
“functional” positions (e.g. sitting in a chair, about to stand up). From these X-rays, the changes in the pelvic and femoral orientations can 
be measured for these functional positions. This data is then used to drive a simulation of the movement of the 3D computer model. The 
orientations of the components of the virtual hip replacement are then adjusted to optimise the biomechanical function of the joint. Once 
the proposed implant positions have been reviewed and approved by the surgeon, a custom-made acetabular orientation guide is 3-D 
printed and sterilised. During the surgery, this guide is fitted into the patient’s acetabulum prior to implanting the components. Using a 
simple system of two sterile laser pointers, the orientation indicated by the guide can then be reproduced when the definitive acetabular 
component is implanted. (More details can be found on the Corin OPS™ website12). There is no published data, however, on the accuracy 
of acetabular component positioning using this particular method. The standard of care in the UK for acetabular component positioning is 
the “freehand technique” described previously. It is important that the impact of this acetabular guide on acetabular component 
positioning be assessed in order to determine whether this intervention is likely to improve patient outcomes and reduce the risk of 
complications of total hip replacement. 
 
Ethical considerations 
6.5
The trial will be conducted in full conformance with the principles of the Declaration of Helsinki and to MRC Good Clinical Practice (GCP) 
guidelines. It will also comply with all applicable UK legislation and the sponsor’s Standard Operating Procedures (SOPs). All data will be 
stored securely and held in accordance with Data Protection Act 1998. Informed consent will be gained from all patients prior to entry in 

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the study. Data will be handled confidentially as laid out clearly in GCP and the sponsors SOP’s. Patient’s safety and well-being will be 
paramount and all patients will be treated with respect and dignity throughout the study.   
 
Consort 
6.6
The trial will be reported in line with the CONSORT (Consolidated Standards of Reporting Trials) statement13   
 
Assessment and management of risk 
6.7
There are risks and benefits to total hip replacement. The main benefit is pain relief resulting in improved function. The major surgical 
risks include infection, leg length discrepancy, venous thromboembolism, dislocation, fracture, nerve injury, arterial injury, and premature 
failure requiring revision. There are also “medical” risks related to anaesthesia and the stress of surgery (eg heart arrhythmias, renal 
failure, etc). The additional risks associated with the new technology are small and the technology is being used according to the 
manufacturer’s guidelines, according to its usual indication. No attributable adverse events have been identified in over 2000 cases 
performed worldwide and over 100 cases in University Hospitals Coventry & Warwickshire (UHCW) NHS Trust. The theoretical additional 
risks of the intervention are:  
 
Malposition or incorrect preparation or insertion of the cup due to either instrument errors or surgeon errors in their use. 
 
Fracture or breakage of the devices, which would have the potential to cause harm, but this would be highly unlikely even in the 
event of an instrument or device breaking. 
Both of these risks are theoretical and have not been observed despite this technology having been used extensively in a number of 
centres, including our own. The other risks are general to total hip replacement and are not unique to this study or increased by the study, 
these are listed under adverse event management. 
7. 
OBJECTIVES AND OUTCOME MEASURES 
 
Primary objective 
7.1
The primary objective is to quantify and draw inferences on the technical accuracy of the treatment groups based on observed differences 
as shown by the difference between planned and achieved acetabular cup anteversion. 
 
Secondary objectives 
7.2
The secondary objectives are:  
To quantify and draw inferences on the efficacy of the treatment groups based on patient reported observed differences.  
 
To assess other technical measurements related to implant positioning. 
 
To observe changes in pelvic motion that occurs because of hip replacement. 
 
To observe if additional complications from the procedure occur. 
 
Primary Outcome Measure 
7.3
 
The difference between planned and achieved acetabular cup anteversion will be assessed by post-operative CT scan performed 
at 6 weeks.  
 
The planned angle in the OPS arm will be determined by the planning software. In the Standard Group, the surgeon will be asked 
before the operation to record the planned position of the cup that they are aiming for (angle of abduction and angle of 
anteversion). In all patients in both groups, the surgeon will also be asked at the end of the procedure to record the final position 
that they believe they placed the component, and to explain any deviation from the planned position. 
 
The CT scans will be measured by a trained medical professional blinded to the treatment allocation. A single individual will 
measure all of the angles but a cohort of 20 scans, randomly chosen, will be measured twice by that individual and by another 
observer to establish inter- and intra-observer error. 

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Secondary Outcome Measure 
7.4
 
The difference between planned and achieved acetabular cup abduction, assessed by post-operative CT scan performed at 6 
weeks. 
 
Treatment efficacy as measured by the following at 6-weeks, 4- and 12-months: 
a) Hip Disability & Osteoarthritis Outcome Score (HOOS)13: a validated, patient-reported measure of hip function. 
b) Oxford Hip Score: a validated, patient-reported measure of hip function. 
c) 
EQ-5D, which is a standardised measure of health and economic outcome. 
 Adverse events data. 
 Leg length discrepancy and femoral offset to be measured on post-operative CT scan by a  medical professional  blinded to the 
treatment allocation 
 
Motion capture data using an accelerometer based motion capture system, performed pre-operatively, and at 12-months. 
8. 
TRIAL DESIGN 
 
Trial Summary 
8.1
A pragmatic single-centre, patient-assessor blinded, randomised controlled trial comparing parallel groups as defined in Figure 1. Trial 
Flowchart.   
It is anticipated the trial will last a total of 30 months (of which 18 months will require funding): 3 months to gain the appropriate 
approvals, 12 months to recruit the patients, 3 months to collect scans required to assess the primary outcome, a further 9 months to 
collect the clinical outcomes and 3 months for analysis of data. 
 
Trial Patients 
8.2
We plan to recruit 54 patients with 27 patients per treatment group (standard and interventional group). All study visits and procedures 
will be conducted at University Hospitals Coventry and Warwickshire NHS Trust. 
 
Eligibility criteria 
8.3
Patients are eligible to be included in the trial if they meet the following criteria: 
8.3.1 
Inclusion criteria 
1. 
All patients undergoing an elective primary unilateral total hip replacement (THR) under the care of an 
orthopaedic consultant at UHCW NHS Trust are eligible for the trial. 
2. 
Provision of written informed consent. 
3. 
Male or Female aged 18-70 years. 
4. 
Able and willing to comply with all study requirements. 
8.3.2 
Exclusion criteria 
1. 
Those patients deemed by the treating clinician as unsuitable for an uncemented primary acetabular 
implant for reasons such as: 
 
 Low demand patient 
 
Osteoporosis 
 
Significant acetabular bone loss 

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2. 
Patients with significant orthopaedic deformities (eg fused knee, hip or ankle). 
3. 
Unable to undergo planning imaging (unable to stand or sit for X-rays, or to lie in a CT scanner). 
4. 
Patients currently receiving ionising radiation treatment or scans for other medical conditions. 
5. 
Previous entry in this trial (contralateral THR). 
6. 
Participation in a clinical trial of an investigational medicinal product in the last 90 days. 
7. 
Pregnant women or women who are trying to become pregnant. 
8. 
Patients who are unable to provide informed written consent 
9.               Patients who require CT planning as part of their standard care 
 
Trial Groups 
8.4
8.4.1 
Standard Group 
Although the fundamental principles of hip replacment are well-established, there are several options at each step of the operation; 
patient positioning, the approach to the hip joint, the type and fixation of the acetabular and femoral components and the closure of the 
wound etc. Patients under this group will be provided THR as per standard care. 
The surgeon will use 2D planning software from pre-operative X-rays to complete surgical planning, and will be asked to record the 
planned position of the acetabular cup at the beginning of the operation using Surgery CRF. Although all patients will undergo CT scans to 
maintain blinding the surgeon will not use the CT scan to plan the procedure, in this case and a custom surgical guide will not be provided. 
At the end of the procedure, the surgeon will be asked to record their assessment of the final orientation of the components, and to 
explain any deviation from the plan. 
8.4.2 
Interventional Group 
Each patient will undergo a pre-operative CT and four plain X-rays, which will be used to accurately plan the hip replacement using the 
Corin OPS™ (Corin Group, Cirencester, UK). All surgeons will have training in the interpretation of the plans produced by the OPS software, 
to ensure consistency with this planning process.   
Surgical approach, patient positioning and local factors will be determined by the operating surgeon. Acetabular cup alignment is normally 
positioned based upon the surgeon’s judgment, which obviously introduces some human error.  In the interventional group, a custom-
made alignment guide will be utilised to aid more accurate positioning of the cup based upon the preoperative CT scan, produced for that 
individual patient. The planned acetabular orientation and guide design will be reviewed pre-operatively by the surgeon, and may be 
amended according to their preferences. The guide is bespoke and fits into the native acetabular socket, and serves to indicate to the 
surgeon the planned acetabular orientation. The planned orientation of the cup will be recorded in the trial documentation. The guide 
does not enforce the surgeon to implant the acetabular component in the planned orientation: it serves purely as an indicator. At the end 
of the procedure, the surgeon will be asked to record their assessment of the final orientation of the components, and to explain any 
deviation from the plan. 
All patients will receive the same design of acetabular component (uncemented Trinity, Corin). The femoral components used will 
normally be the uncemented Metafix stem (Corin), but in some patients a cemented Taperfit stem (Corin) will be used if the surgeon 
deems it to be more suitable for that particular patient. These implants are fully compatible with Corin OPS and non-OPS hip replacement 
procedures. All surgical procedures will be undertaken by consultant surgeons who are experienced in performing hip replacements both 
with and without the Corin OPS methodology, and in the use of the above implants. 
All patients in the trial will undergo pre and postoperative CT scans to enable accurate assessment of the primary outcome. 
Further details on the Corin OPS™ is attached in Appendix 1. 

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 Surgical Device          
8.5
8.5.1 
Implant and device storage and implementation 
The trial surgeons have both had full training in the use of all techniques and devices used in the study. All surgical equipment required for 
the study will be stored at Rugby St Cross Hospital in the theatre suite. All implant guides will be clearly marked with the patient name and 
this will be checked both by the theatre staff and the surgeon as is normal practice. Representatives of the company will be available to 
give advice in the operating theatre if required, according to normal clinical practice.  
Further details on the Corin OPS™ are attached in Appendix 1. 
9. 
TRIAL PROCEDURES & VISITS 
 
Patient Identification 
9.1
Patients undergoing an elective primary unilateral total hip replacement (THR) under the care of an orthopaedic consultant at UHCW NHS 
Trust are potentially eligible to take part in the study. Such patients will be approached by a member of their direct healthcare team to 
inform them about the study. Patients that are interested in finding out more will be referred to a member of the study team, who will 
explain the study and provide the patient with the PIS to take home. At least 7 days after the patient has received the PIS, a member of 
the study team will call the patient to receive their verbal consent for participation over the telephone.  
9.1.1 
Informed Consent 
Patients will be asked to confirm whether they have read and understood the PIS and will be encouraged to ask questions and be 
provided enough opportunities to discuss before deciding to take part in the study.  Patients will be free to discuss the study with friends 
and family before reaching their decision. 
 
After confirming the patient’s eligibility to take part, a qualified member of the research team, who has received training in obtaining 
informed consent,  will ask the patient to provide verbal consent to each of the clauses contained within the telephone consent form. The 
research team member will record the participant’s responses on the informed consent form, sign and send a copy to the patient in the 
post. The patient will be asked to countersign the consent form at their next face-to-face contact with the trial team.  
Patients will be made aware that they are free to withdraw their consent to participate and/or their data at any time without giving a 
reason and that their decision to participate will not influence their current or future care in any respect. Patients will be asked to read the 
consent form thoroughly and initial against each point to signify their agreement at a time when it is convenient for the patient. Forms will 
be signed and dated by both the patient and the researcher taking consent. Patients will be provided with a copy of the consent form, a 
second (original) copy will stored securely at the study site and a third will be stored in the patient’s hospital medical notes.  
Consent will be obtained prior to conducting any trial related assessments and/or procedures. Patients unable to consent for themselves 
will not be included in the trial.  
If the patient verbally consents to participate, the study team will book the patient’s baseline imaging to be taken at study visit 1 and 
complete baseline observations as follows: 
1. Demographics – name, date of birth, hospital number, height, weight, ethnicity 
2. Medical history – hip side, hip pathology, contralateral hip pathology or surgery, spine pathology or surgery, neurological conditions 
and other medical conditions 
3. Current Medications – current and relevant medication 
4. Clinical assessment – will be completed by the treating clinician to assess wound healing, perceived leg length difference, walking aids 
etc. 
5. Patient questionnaire – the questionnaire will comprise of validated assessments: HOOS, EQ-5D and Oxford hip score 
If any observations cannot be completed via telephone, they will be completed at visit 1.   

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It is expected that recruitment will take 12 months for the proposed trial. If recruitment is significantly behind target, other surgeons 
within the hospital will be asked to refer patients on to the CI  for potential participation in the study.  
 
Visit 1- Baseline & Imaging 
9.2
9.2.1 
Baseline observations 
 
Imaging  
9.3
All patients will undergo the following imaging procedures at visit 1:. 
X-ray and motion capture– standing AP pelvic X-ray, 3 lateral lumbar spine X-rays, with small wearable accelerometers simultaneously 
placed on the patient (using a Velcro strap). The date performed and problems encountered (practical, image quality), if any, will be 
recorded. Motion capture will only be taken if the appropriate staff are available to do so. 
CT Scan – will be performed in accordance to the methodology attached in Appendix 2. Information will be recorded on Pre-Op Imaging 
CRF. If patients have had a valid CT scan 12 months prior to consenting for this study, they may not be required to have an additional 
baseline CT scan to avoid exposing the patient to more radiation if not necessary. 
Randomisation – the research team will contact R&D Randomisation Unit to randomly assign patients to the Standard Group and 
Interventional Group as per section below. 
 
Randomisation 
9.4
After completing imaging assessments, the researcher will contact R&D Randomisation Unit (contact details below) based at UHCW NHS 
Trust during office hours 9 am to 5pm to complete patient randomisation. Randomisation information will be recorded on the 
Randomisation CRF.   
 
 
 
 
 
 
As this is an elective surgery study, there is no need for out-of-hours randomisation. 
Participants will be randomised strictly sequentially as participants are eligible for randomisation using a 1:1 ratio. The randomisation will 
be stratified by operating surgeon and by patient BMI group (BMI<30 v ≥30). Randomisation information will be recorded on 
Randomisation CRF.   
 
 
Visit 2 – Surgery 
9.5
The surgeries will be performed at Rugby St Cross Hospital. The treating surgeon who will remain unblinded to the study will record 
relevant information on Surgery CRF. More information on blinding and unblinding can be found in section 10. Prior to discharge all 
patients will receive AP pelvic X-ray as part of standard care.  
 
Visit 3- Follow Up (6 weeks ± 2 w) 
9.6
This will be the first follow up post-surgery and patients will be required to complete CT scan. Where possible, CT scan will be completed 
at visit 3. However, on occasions, patients may be provided with a separate appointment to complete scanning depending on availability 
of the imaging facility at the Trust. Information will be recorded on Post-Op Imaging CRF. Clinical assessment will be performed at visit 3 
and information collected will be recorded on the Follow up CRF and patient questionnaires will be collected. Any adverse events (AEs) 
will be observed face to face at consultation or based on information volunteered by the patient at the visit. AEs will be recorded on to the 
R&D Randomisation Unit 
University Hospitals Coventry & Warwickshire NHS Trust 
4th Floor Rotunda, Clifford Bridge Road 
Coventry CV2 2DX 
Office hours: 9 am to 5 pm. 
Tel: 024 7696 6199 or 024 7696 27476 

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CRF and reported as per procedure described in section 13. If the patient’s follow-up appointment is delayed outside this 6 week time 
point range, then their data can be collected by phone. 
 
Visit 4 – Follow Up (4 months ± 6w) 
9.7
Visit 4 follow up is not a clinic appointment. It will be completed via phone and post. Patient questionnaires will be provided via post to 
return to the research team using a pre-paid self-addressed envelope. Information collected at the visit will be recorded on the Follow up 
CRF. AEs, if any, will be recorded on to the CRF and reported as per procedure described in section 13. 
 
Visit 5 – Follow Up (12 months ± 2m) 
9.8
This is the final follow up and denotes the end of participation for patients. Patients will be required to complete motion capture, X-ray 
imaging and patient questionnaire. Motion capture will only be taken if the appropriate staff are available to do so. Information collected 
at the visit will be recorded on the Follow up CRF. AEs, if any, will be recorded on to the CRF and reported as per procedure described in 
section 13. End of study CRF will be completed as this will be the last scheduled study visit. Following this the patients will be either be 
followed up as per standard care or discharged back to GP. If the patient’s follow-up appointment is delayed outside this 12 month time 
point range, then their data can be collected by phone. 
10. 
BLINDING & UNBLINDING 
This is a patient-assessor blinded study where neither the patient nor the study team recording data will know what arm the patient has 
been allocated to.  
However, the CI and/or senior-most scrubbed surgeon will remain unblinded to the treatment allocation as it is not possible to blind them 
to the allocation group. 
 
Methods for ensuring blinding    
10.1
It will not be possible to blind the surgeon administering the intervention. However, the patients and researcher recording study data and 
performing follow ups will be blinded as there will be no external difference in the appearance to inform which operation has taken place 
(the scar and approach is identical).  
Primary outcome measures will be assessed via CT and all staff performing scans and measuring the outcome will be blinded to the 
allocation. Secondary outcome measures will be collected, either prior to discharge, by post, by telephone or by the research team, who 
will be blinded to the treatment allocation.  
The trial statistician will also be blinded to the intervention groups throughout. Blinding will be maintained when generating the 
randomisation lists by using group names “A” and “B”. The patients will be assigned to these groups by the R&D Randomisation Unit 
which is independent from the rest of the study team. 
 
Methods for unblinding the trial 
10.2
Unblinding in the study is not allowed unless there are medical or safety reasons to do so. Unblinding can occur 24 hours a day and 7 days 
a week during office hours (Monday to Friday; 9 am to 5pm) by calling the clinical team on 024 7696 4209 or 024 7696 5065 or if out of 
hours, ring hospital switchboard on 02476 964000 and ask for Prof King or Mr. Foguet. Where possible, the CI and/or the sponsor should 
be informed before unblinding. Treatment codes will not be broken for the planned analyses of data until all decisions on the evaluability 
of the data from each individual patient have been made and documented.  
The method of unblinding ensures that the data for only one patient is disclosed at any one time. This will be by code break envelopes 
made by trial statistician. There will be 2 sets of envelopes providing emergency unblinding to treatment code, one to be kept with the 
clinical team in the Orthopaedic department for use in-case of unblinding, and the second set to be kept with the Sponsor as a backup in 
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11. 
TRIAL WITHDRAWALS  
Patients may be discontinued from the trial treatment and/or the trial at any time without prejudice. The data collected up to the point of 
withdrawal will be retained unless a patient specifically requests it to be removed 
 
Post-randomisation withdrawals  
11.1
Should a patient withdraw from the trial after randomization, he/she will continue to be treated as per routine clinical practice.  
 
Concomitant illness withdrawals 
11.2
Details of any concomitant illness (any illness present at the start of the trial) will be recorded at trial entry. If the change influences the 
patient’s eligibility to continue in the trial (i.e. the patient is unable to have the planned surgery or continue participation), the CI must be 
informed and the patient withdrawn. 
 
Concomitant medication withdrawals 
11.3
Details of any relevant concomitant medication (any medication that could affect the performance of the surgery, such as anticoagulants) 
should be recorded at trial entry. Any changes in relevant concomitant medication should be recorded at each visit. If the change 
influences the patient’s eligibility to continue in the trial (i.e. the patient is unable to have the planned surgery), the CI must be informed 
and the patient withdrawn 
 
Other withdrawals  
11.4
The patient will be required to discontinue participation in the trial under the following circumstances: 
 
Patient wishes to withdraw for any reason 
 
Non-compliance to protocol 
 
CI’s decision that withdrawal from the trial is in the best interest of the patient 
 
AE related 
 
Sponsor’s decision 
 
Lost to follow up 
If the patient needs to be withdrawn from the trial for any of the above reasons, Withdrawal CRF will be completed. Where possible, 
the reason for the withdrawal from the study will be recorded. 
12. 
END OF TRIAL 
The trial will end when all patients have completed their 12-month follow up, although long term follow up (5 and 10 years) may be 
planned depending on further funding. At this 12-month point, all patients will be treated as per the standard of care. 
The trial will be stopped prematurely if: 
 
Mandated by the regulatory authorities 
 
Funding for the trial ceases 
The regulatory authorities will be notified in writing within 90 days when the trial has been concluded or within 15 days if terminated 
early. 
13. 
SAFETY MONITORING AND REPORTING 
 
Definitions (from ISO/FDIS 14155) 
13.1
13.1.1 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device. 

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NOTE 1- This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the 
installation, the operation, or any malfunction of the investigational medical device. 
NOTE 2- This includes any event that is a result of a use error or intentional misuse. 
13.1.2 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) 
in subjects, users or other persons whether or not related to the investigational medical device. 
NOTE 1: This includes events related to the investigational device  
NOTE 2: This includes events related to the procedures involved (any procedure in the protocol). 
NOTE 3: For users or other persons this is restricted to events related to the investigational medical device. 
The following adverse events are expected and will be recorded on the CRF:: 
 
Related in general to surgery and anaesthetic 
• 
Chest infection 
• 
Urinary tract infection 
• 
Myocardial infarct 
• 
Stroke 
 
Related to Total Hip Replacement 
• 
Infection 
• 
Dislocation 
• 
Leg length discrepancy 
• 
Bleeding 
• 
DVT/PE 
• 
Damage to nerves in the surgical area 
13.1.3 
Device deficiency 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or 
use error and inadequate labelling. 
13.1.4 
Investigational medical device 
Medical device being assessed for safety or performance in a clinical investigation. 
13.1.5 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. 
13.1.6 
Serious Adverse Event (SAE) 
Adverse event that: 
a) led to a death, 
b) led to a serious deterioration in health that either: 
1) resulted in a life-threatening illness or injury, or 
2) resulted in a permanent impairment of a body structure or a body function, or 
3) required in-patient hospitilisation or prolongation of existing hospitilisation, or 

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4) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or 
a body function. 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE 1: This includes device deficiencies that might have led to a serious adverse event if: a) suitable action had not been taken or b) 
intervention had not been made or c) if circumstances had been less fortunate. These are handled under the SAE reporting system. 
NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by the Clinical Investigation Plan, without a serious 
deterioration in health, is not considered to be a serious adverse event. 
13.1.7 
Unanticipated Serious Adverse Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk 
analysis report. 
NOTE: Anticipated: an effect which by its nature, incidence, severity or outcome has been previously identified in the risk analysis report. 
 
Reporting procedures 
13.2
Patients will have direct contact with the trial team by telephone and email to report any events themselves.  
13.2.1 
Reporting of ADEs and AEs  
AEs and ADEs could be observed directly when patients attend follow-up appointments or when volunteered by the patient. Unscheduled 
clinic visits will be arranged if further clinical care is required following an AE.  All non-serious AEs/ADEs should be reported or 
documented as soon as possible but no later than a month on the AE form and then recorded onto the trial database. If the outcome to 
the AE is serious then an SAE form should be completed.  
13.2.2 
Reporting of SAEs/SADEs and USADEs  
The EC Medical Devices Directive (93/42/EEC) requires a manufacturer to fully record all adverse incidents that occur during a clinical 
investigation and include them in the annual reports to the main REC (and MHRA if appropriate). The legal responsibility for reporting 
SAEs/SADEs lies with the manufacturer or their authorised representative. However, the MHRA also has a voluntary reporting 
requirement for ‘users’ of devices i.e. where a device is being used in a trial in which the manufacturer has no involvement, and in this 
case, the coordinating centre would submit the appropriate reports and also inform the manufacturer of the event.  
All SAEs/SADEs and USADEs occurring from the time of surgery until 90 days post-surgery must be recorded on the SAE form and reported 
to the Sponsor within 24 hours of the research staff becoming aware of the event.  An initial report may be made orally but must be 
followed up promptly by a detailed written report. SAE form will be completed together with relevant supporting documents, including an 
assessment of severity, causality and expectedness, as reviewed by the chief investigator or other medical professional. SAE form should 
be submitted to the sponsor’s office at RD&Isponsorship@uhcw.nhs.uk. A report will also be submitted to the manufacturer (Corin) via 
their existing vigilance system. 
For each SAE the following information will be collected: 
 
full details in medical terms and case description 
 
event duration (start and end dates, if applicable) 
 
action taken 
 
outcome 
 
seriousness criteria 
 
causality (i.e. relatedness to trial device / investigation), in the opinion of the investigator 
 
whether the event would be considered expected or unexpected. 
The seriousness, causality & expectedness of an SAE will be reviewed by the CI for reporting purposes 
 

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Relationship  
to trial procedure 
Description 
Unrelated 
There is no evidence of any causal relationship 
Unlikely to be related 
There is little evidence to suggest there is a causal relationship 
(e.g. the event did not occur within a reasonable time after 
administration of the trial medication or device).  There is 
another reasonable explanation for the event (e.g. the 
patient’s clinical condition, other concomitant treatment). 
Possible relationship 
There is some evidence to suggest a causal relationship (e.g. 
because the event occurs within a reasonable time after 
administration of the trial medication or device).  However, 
the influence of other factors may have contributed to the 
event (e.g. the patient’s clinical condition, other concomitant 
treatments). 
Probable relationship 
There is evidence to suggest a causal relationship and the 
influence of other factors is unlikely. 
Definitely related 
There is clear evidence to suggest a causal relationship and 
other possible contributing factors can be ruled out. 
 
Any change of condition or other follow-up information should be emailed to the Sponsor as soon as it is available or at least 
within 24 hours of the information becoming available. Events will be followed up until the event has resolved or a final outcome 
has been reached.   
14. 
TRIAL RESPONSIBILITES 
 
Sponsor: 
14.1
UHCW NHS Trust has agreed to act as sponsor for this trial and will undertake the responsibilities of sponsor as defined by the Research 
Governance Framework and ICH Good Clinical Practice.  An authorised representative of the Sponsor has approved the final version of this 
protocol with respect to the trial design, conduct, data analysis and interpretation and plans for publication and dissemination of results. 
The sponsor provides indemnity for this trial and, as such, will be responsible for claims for any non-negligent harm suffered by anyone 
because of participating in this trial. The indemnity is renewed on an annual basis and will continue for the duration of this trial. 
 
Chief Investigator: 
14.2
CI’s responsibilities include, but are not limited to: 
 
Ensuring that the trial is conducted as set out in the protocol and supporting documents. 
 
Delegating trial related responsibilities only to suitably trained and qualified personnel and ensuring that those with delegated 
responsibilities fully understand and agree to the duties being delegated to them. 
 
Ensuring that CVs and evidence of appropriate training for all Site staff are available in the Trial Site File 
 
Ensuring that all delegated duties are captured in the study Delegation Log 
 
Ensuring all Adverse Events are documented and reported promptly to the Trial Manager 
 
Prepare an annual safety report for the REC and MHRA  
 
Accountability for trial treatments at their site 
 
Ensuring the trial is conducted in accordance with ICH GCP principles 
 
Allowing access to source data for monitoring, audit and inspection 

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Trial Management Group (TMG): 
14.3
TMG will have the responsibility for overseeing the day to day coordination of the trial, monitoring all aspects of the conduct and progress 
of the trial, ensuring that the protocol is adhered to and taking appropriate actions to safeguard participants and the quality of the trial 
itself. TMG meetings will take place regularly throughout the project along with the CI.   
15. 
DATA MANAGEMENT 
Personal data collected during the trial will be handled and stored in accordance with the 1998 Data Protection Act and GCP.  
 
Data collection and management 
15.1
Case Report Forms (CRFs) will be developed to collect all required trial data and will be designed by the trial team in consultation with the 
chief investigator and statistician. All participants will be assigned a unique trial ID, which will be used to identify all data associated with 
the patient for the duration of the trial. 
All of the data collected in this trial will be entered into a secure trial database held at University Hospitals Coventry and Warwickshire.  
Specifications for the trial database will be agreed between the statistician and the CI. The procedure for data entry will be confirmed 
upon construction of the database and a trial specific data management plan will be developed.   
In the event of missing data, the relevant clinical databases and case report forms will be accessed to complete the database. 
 
Data storage 
15.2
All essential documentation and trial records will be stored by UHCW in conformance with the applicable regulatory requirements and 
access to stored information (paper and electronic) will be restricted to authorised personnel. All paper data will be stored in a designated 
storage facility within the Clinical Sciences Building on the research site at UHCW.  Data will also be stored on password protected 
University of Warwick and UHCW NHS Trust computers in a restricted access building. 
 
Data access and quality assurance 
15.3
All data collected will be anonymised after the collection of the baseline demographic data for each patient. Confidentiality will be strictly 
maintained and names or addresses will not be disclosed to anyone other than the staff involved in running the trial.  Identifiable patient 
data will be held in a locked filing cabinet and coded with the trial number to tag identifiable data to the outcome data. 
Direct access to source data/documents will be available for trial-related monitoring or audit by UHCW for internal audit, regulatory 
authorities or ethics committees. 
 
Archiving 
15.4
Trial documentation and data will be archived for 25 years after completion of the trial, in line with current UHCW Trust policy. 
16. 
STATISTICAL ANALYSIS 
 
Power and sample size 
16.1
A sample size of 54 patients has been calculated. 
 
The primary outcome for the study is the difference between the planned and achieved acetabular cup position. Assuming a standard 
deviation of the difference in cup position of 10° (based on multiple studies of both standard techniques and computer aided techniques) 
and a minimal clinically important difference of 10° in the primary outcome (based on Lewenick’s ‘safe zone’ concept), power of 90% and 
alpha set at 0.05, a sample size of 44 was calculated. With 20% added for loss to follow up, 54 patients will be recruited into this study, 27 
in each allocation arm.  

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Statistical analysis of efficacy and harms  
16.2
16.2.1 
Data analysis 
The study statistician will be responsible for the overall analysis of the data in conjunction with the CI and co-investigators 
The main analysis will investigate differences in the primary outcome measure : difference between planned and achieved acetabular 
anteversion angle (as defined above). An intention to treat analysis will be used unless otherwise specified. Therefore, all randomised 
patients will be included, regardless of protocol adherence and will be retained in the group to which they were allocated in the 
randomisation. 
Standard statistical summaries (e.g. medians and ranges or means and variances, as appropriate) and graphical plots will be presented for 
the outcome measures described above. Baseline data will be summarised to assess comparability between treatment arms. 
The mean of the primary outcome measure between treatment groups will be assessed using t-tests; based on an assumed approximate 
normal distribution for this outcome. Tests will be two-sided and considered to provide evidence for a significant difference if p-values are 
less than 0.05 (5% significance level). Estimates of treatment effects will be presented with 95% confidence intervals.  
The randomisation will be stratified according to surgeon and BMI group, however the effects of patient age and gender on the treatment 
effect will be quantified using linear regression analysis that includes these two variables in addition to the main treatment factor. Results 
from these adjusted and the unadjusted analyses will be presented graphically, to aid interpretation. The reasons and patterns of any 
missing data will be carefully considered, and if judged significant, missing data will be imputed. 
 Depending on the nature of the data, various derived variables (e.g. logarithmic transformations of scores) may be created and analysed, 
in addition to the primary outcome. Secondary outcome measures will be analyzed in a similar manner. The statistical analysis will mainly 
be carried out using R (http://www.r-project.org/) . A consort flow diagram will be produced (http://www.consort-statement.org/). 
16.2.2 
Planned recruitment rate 
Over 500 patients have their hip arthroplasty at UHCW each year. From our previous investigations, we estimate that approximately 80 
patients annualy would be suitable for this trial. In a previous study, comparing two different types of hip replacement surgery, it was 
shown that patients willingness to take part in trials comparing two different surgical procedures is very high (80%). With a conservative 
estimate of 70% of patients willing to take part in this trial, it is expected that recruitment will take 12 months for the proposed trial. 
Therefor our planned recruitment rate is 4.5 patients/month. 
17. 
TRIAL ORGANISATION AND OVERSIGHT 
 
Sponsor and governance arrangements 
17.1
The trial will be sponsored by the University Hospitals Coventry and Warwickshire NHS Trust and funded by Corin Ltd, UK.  
 
Regulatory authorities/ethical approval 
17.2
All required ethical approval(s) for the trial will be sought using the Integrated Research Application System. The trial will be conducted in 
accordance with all relevant regulations. Patients will not be enrolled into the trial until written confirmation of R&D approval is received 
by the research team.  
Substantial protocol amendments will be submitted (e.g. changes to eligibility criteria, outcomes, analyses) to relevant parties i.e. 
investigators, RECs, patients, NHS Trusts, regulators, trial registries, journals as required. 
Annual reports will be submitted to the REC within 30 days of the anniversary date on which the favourable opinion was given, and 
annually until the trial is declared ended. The REC will be notified of the end of the trial (whether at planned time or prematurely). The CI 
will submit a final report to the required authorities with the results, including any publications within one year of the end of the trial. 

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Trial Registration 
17.3
The trial will be registered with the International Standard Randomised Controlled Trial Number (ISRCTN) Register and also on 
clinicaltrials.gov. 
 
Notification of serious breaches to GCP and/or trial protocol 
17.4
A “serious breach” is a breach which is likely to effect to a significant degree – 
(a) the safety or physical or mental integrity of the subjects of the trial; or 
(b) the scientific value of the trial 
In the case of a serious breach of the trial protocol: 
 
the sponsor will be notified immediately of any case where the above definition applies during the trial conduct phase 
 
the sponsor will notify the REC in writing of any serious breach of 
(a) the conditions and principles of GCP in connection with that trial; or  
(b) the protocol relating to that trial, as amended from time to time, within 7 days of becoming aware of that breach 
 
Indemnity 
17.5
NHS indemnity covers NHS staff, medical academic staff with honorary contracts, and those conducting the trial.  NHS bodies carry this 
risk themselves or spread it through the Clinical Negligence Scheme for Trusts, which provides unlimited cover for this risk.  
 
Trial timetable and milestones 
17.6
Start Date: August 2017 
Prior to start of funding (-3 to 0) 
Compilation of CRF’s, Research Ethics Application – to be led by the CI along with the TMG. 
Lead time (Months 0 to 3): 
Finalisation of data collection sheets relevant approvals and contracts to be led by the CI along with TMG 
Training of research team to be led by the CI and co-investigators 
Recruitment of patients (Months 3 to 15): Trial starts 
Recruitment targets to be achieved through clinical collaborations between the CI and local research associates. Recruitment targets to be 
monitored by the TMG. 
Follow-up of patients for the primary outcome (Months 15 to 18): 
Clinical follow up at six weeks, by the research team. Requesting of CT scans by the clinical teams caring for the patient, monitored by the 
research team. Measuring of the CT scans by an appropriately trained professional, after training by the CI and/or co-investigators. 
Follow-up of patients for the secondary outcomes (Months 15 to 27): 
Follow-up at four and twelve months by the research associate under the supervision of the CI. 
Analysis and reporting (Months 27-30): 
Trial statistician will be responsible for the overall analysis of the data in conjunction with the CI and co-investigators.  
 
 
Essential Documentation 
17.7
A Trial Master File will be set up according to sponsor’s SOP and held securely at the R&D department.  

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18. 
INTELLECTUAL PROPERTY 
There is the potential for the generation of Intellectual Property (IP) as a result of the findings of this trial. Should any IP sensitive findings 
be uncovered, the Research Team will liaise direct with the Trust IP adviser (G. Smallman) and an exploitation plan will be developed. 
19. 
MONITORING, AUDIT AND INSPECTION 
Adverse event monitoring and procedures have been dealt with in section 8. 
The trial will be regularly audited and monitored by UHCW in their role as sponsor. The analysis of the primary outcome measure will be 
audited by the research team and a random sample of the CT’s will be measured by a second observer to assess the inter-observer 
reliability of the measurement. 
20. 
PATIENT AND PUBLIC INVOLVMENT (PPI) 
As part of patient and public involvement in our study, we have asked a patient to comment on the design and undertaking of the 
research. This included consultation on key trial documents such as protocol, PIS and consent form.  
21. 
DISSEMINATION AND PUBLICATION 
The results of the trial will be reported first to trial collaborators.  The main report will be drafted by the trial team who will agree on the 
final document. 
The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines (www.consort-
statement.org). 
In consultation with our patient members, we plan to present the research findings to the entire NHS via the NHS national electronic 
Library for Health (NHS Evidence).  
The study protocol for the full trial will be published in a high impact peer reviewed journal. The final results will be submitted for 
publication, alongside presentations at annual meetings of the British Orthopaedic Association (BOA), and the British Hip Society (BHS). 
We also plan to present internationally at the American Academy of Orthopaedic Surgeons (AAOS). 
We anticipate that the results of this trial will also inform the development of future multi-centre trials in hip arthroplasty with the 
potential to influence policy and practice in the UK and worldwide. 
22. 
REFERENCES 
1.  
National Joint Registry. 12th Annual Report. 12th Annu Rep. 2014;12(December 2014):81–8.  
2.  
Parvizi J, Sharkey PF, Bissett GA, Rothman RH, Hozack WJ. Surgical treatment of limb-length discrepancy following total hip 
arthroplasty. 
J 
Bone 
Joint 
Surg 
Am 
[Internet]. 
2003 
Dec;85–A(12):2310–7. 
Available 
from: 
http://www.ncbi.nlm.nih.gov/pubmed/14668499 
3.  
Kennedy JG, Rogers WB, Soffe KE, Sullivan RJ, Griffen DG, Sheehan LJ. Effect of acetabular component orientation on recurrent 
dislocation, pelvic osteolysis, polyethylene wear, and component migration. J Arthroplasty [Internet]. 1998 Aug;13(5):530–4. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/9726318 
4.  
Beverland DE, O’Neill CKJ, Rutherford M, Molloy D, Hill JC. Placement of the acetabular component. Bone Joint J [Internet]. 
2016;98–B(1 Suppl A):37–43. Available from: http://www.bjj.boneandjoint.org.uk/content/98-B/1_Supple_A/37 
5.  
Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint 
Surg Am [Internet]. 1978 Mar;60(2):217–20. Available from: http://www.ncbi.nlm.nih.gov/pubmed/641088 

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6.  
Sariali E, Boukhelifa N, Catonne Y, Pascal Moussellard H. Comparison of Three-Dimensional Planning-Assisted and Conventional 
Acetabular Cup Positioning in Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am [Internet]. 2016 Jan 
20;98(2):108–16. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26791031 
7.  
Mannan A, Smith TO. Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-
analysis. Knee [Internet]. 2016 Mar;23(2):186–90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26782300 
8.  
Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi A V. Improved accuracy of alignment with patient-specific positioning guides 
compared with manual instrumentation in TKA. Clin Orthop Relat Res [Internet]. 2012 Jan;470(1):99–107. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/21809150 
9.  
Small T, Krebs V, Molloy R, Bryan J, Klika AK, Barsoum WK. Comparison of acetabular shell position using patient specific 
instruments vs. standard surgical instruments: a randomized clinical trial. J Arthroplasty [Internet]. 2014 May;29(5):1030–7. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/24231437 
10.  
Hananouchi T, Saito M, Koyama T, Hagio K, Murase T, Sugano N, et al. Tailor-made surgical guide based on rapid prototyping 
technique for cup insertion in total hip arthroplasty. Int J Med Robot [Internet]. 2009 Jun;5(2):164–9. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/19248055 
11.  
Buller L, Smith T, Bryan J, Klika A, Barsoum W, Iannotti JP. The use of patient-specific instrumentation improves the accuracy of 
acetabular 
component 
placement. 
J 
Arthroplasty 
[Internet]. 
2013 
Apr;28(4):631–6. 
Available 
from: 
http://www.ncbi.nlm.nih.gov/pubmed/23498350 
12.  
CorinGroup. 
No 
Title 
[Internet]. 
[cited 
2017 
Jan 
4]. 
Available 
from: 
http://www.coringroup.com/medical_professionals/products/hips/corin_ops/ 
13.  
Moher D, Schulz KF, Altman DG, Lepage L. The CONSORT statement: Revised recommendations for improving the quality of 
reports of parallel-group randomised trials. Vol. 357, Lancet. 2001. p. 1191–4.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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23. 
APPENDIX 1. 
 
 
OPSTM Dynamic Hip Analysis 
INSTRUCTIONS FOR USE 
www.coringroup.com 
OPS.customerservice@coringroup.com 
Manufacturer 
Optimized Ortho Pty Ltd 
17 Bridge Street Pymble 
NSW 2073 AUSTRALIA 
Authorised Representative 
Corin Limited 
The Corinium Centre 
Cirencester GL7 1YJ 
UNITED KINGDOM 
Intended Use 
The Optimized Positioning SystemTM (OPSTM) Dynamic Hip Analysis is 
intended to assist with alignment of components during total hip 
arthroplasty. 
Product Description 
The OPSTM Dynamic Hip Analysis is a computer software package used 
to generate simulations of a total joint replacement from patient imaging. 
The dynamic simulation is used for operative planning, including implant 
selection, sizing and placement; and to create custom instruments or 
delivery specifications referencing the patient's anatomy and bio-
mechanics. The simulation can also be used for the post-operative 
evaluation of joint performance. 
Materials 
OPSTM Dynamic Hip Analysis is Class IIa standalone medical device 
software. The simulation code is compiled in MSC Adams, a computer 
aided engineering package for multi-body dynamics and motion analysis. 
OPSTM Dynamic Hip Analysis can be used for patient specific post-
operative or pre-operative analysis. 
A suite of macros apply the same physical manoeuvres and test 
conditions to any number of patient inputs. A unique three-dimensional 
musculoskeletal model is created for each individual that defines the 
position of implant components in the joint. 
The hip model simulates a sit-to-stand event and a step-up event. 
Software Modules and Functions 
Surgery 
Analysis Type 
Total Hip Arthroplasty 
Post-Operative 
Pre-Operative 
 
Indications 
Post-operative OPSTM Dynamic Hip Analysis is indicated for patients who 
have received a total hip replacement where implant geometry is 
supported by the software. 
Pre-operative OPSTM Dynamic Hip Analysis is indicated for primary total 
hip replacement and revision hip arthroplasty where the implant system is 
supported by the software. 
Contraindications 
OPSTM Dynamic Hip Analysis is contraindicated for: 
 
Patients in which total hip arthroplasty is contraindicated 
 
Patients with significant orthopaedic deformities, e.g. fused 
knee, hip or ankle. 
 
Patients who are unable to comply with imaging requirements 
 
Patients currently receiving ionising radiation treatment or scans 
for other medical conditions 
 
Implant systems that are not supported by the software – if 
unsure of whether a hip arthroplasty system can be analysed, contact 
your product representative or Corin before placing a booking or 
requesting patient imaging. 
Conditions Affecting Performance, Side Effects and Adverse Effects 
The accuracy of the reported information and quality of the simulation is 
dependent on a number of factors: 
 
Quality of CT scans – the prescribed Corin protocol has been 
designed to minimise the radiation dosage, while retaining sufficient 
detail in the structures for a patient specific three dimensional model of 
the joint. 
 
Quality of X-rays – the protocol describes the key landmarks 
and functional positions required for the patient specific dynamic 
analysis. 
 
Provision of correct implant system details (manufacturer, 
model, and size for a post-operative analysis) to import matching 
implant geometry into the model. 
Corin requires patient details and imaging for pre-operative analyses a 
minimum of five weeks prior to the surgery date. For requests submitted 
after this time, delivery of the report cannot be guaranteed; however, all 
attempts will be made to accommodate requests at short notice. 
Incorrect use of the OPSTM Dynamic Hip Analysis information may lead 
to an increased risk of poor functional outcomes including, but not limited 
to, hip dislocation, hip edge loading, squeaking in ceramic hip implants, 
increased wear debris, pain, decreased range of motion and soft tissue 
impingement. 
Warnings and Precautions 
 
The information generated by the software are predictions of the 
dynamic behaviour of the total joint replacement, derived from a three 
dimensional model constructed using the patient’s bone geometry. 
 
The information applies only to the patient identified, listed 
implant models and side of analysis. 
 
The dynamic results must not be used to alter the treatment 
regime of another patient. 
 
The dynamic results must not be used to treat a side other than 
what is specified in the analysis. 
 
The information applies only to controlled dynamic events (sit-
to-stand and step-up) and must not be used to draw conclusions 
outside the simulated actions. 
Restrictions and Limitations on Use 

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Use of information generated with OPSTM is restricted to registered 
orthopaedic surgeons. The information may not be used by implant 
manufacturers for unauthorised purposes, including evaluation and 
design of total joint replacement systems. 
The results of the patient specific analyses are based on radiographic 
imaging acquired on the date specified in the patient specific reports.

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Caution 
Consult instructions for 
use 
Authorised 
Representative 
Manufacturer 
OPT-REC-RA-06 Rev 10
 
Report Contents and Interpretation of Results 
The results of the analysis are presented in PDF format, with embedded 
Flash video clips. 
Corin takes all feasible measures to ensure that the report file is not 
corrupted and free from malware. In the event of a corrupted or infected 
file, do not attempt to open the report. Contact your product 
representative or Corin for a replacement file. 
Use the following controls to view and navigate the animations in the 
report. 
Play - click to start the video clip 
Pause - click to pause the video clip 
Stop - click to stop the video clip 
Current Time Indicator - click and drag this along the time bar 
to move forward or backward in the video clip 
The hip animations display the model and implants during the simulated 
sit-to-stand activity and step-up event in medial-lateral and anterior-
posterior views. 
The polar plots display the articulating surface of the acetabular liner, 
divided into 5 concentric rings, where the angle subtended at the liner 
centre corresponds to 5% increments of the cup articular arc angle. The 
outermost bolded ring represents the rim of the acetabular liner. The polar 
plots are specific to the implant model, type and size used in the analysis. 
Hip joint mechanics are represented by a circle (contact patch area 
between liner and femoral head, derived from Hertzian contact 
mechanics) and the centre point of this circle (resultant hip force). 
During motion the contact patch and resultant hip force trace a path on the 
articulating surface of the acetabular liner. This is dependent on individual 
pelvic dynamics. The polar plot shows the locus of the resultant hip force 
and path of the head-liner contact patch for the specified acetabular 
orientation during the sit-to-stand event (blue) and the step-up event (red). 
 
The cup orientation for each polar plot is given in degrees of radiographic 
inclination, followed by degrees of radiographic anteversion referenced to 
the coronal plane when supine. The following definitions are applied: 
 Inclination - angle between the longitudinal axis and the acetabular axis 
when this is projected on to the coronal plane 
 Anteversion - angle between the acetabular axis and the coronal plane 
(Murray, 1993)1 
 Edge loading - when contact patch between the femoral head and 
acetabular liner passes over the true rim of the liner 
 Supine pelvic tilt - angle between the coronal plane and anterior pelvic 
plane when supine; a negative value represents a posterior pelvic tilt 
In pre-operative hip simulations, unless otherwise specified by the 
orthopaedic surgeon user, the preferred cup orientation is derived from a 
series of clinical preferences, captured for each surgeon user and aimed to 
maximise the distance of both outermost contact patch areas from the rim 
of the acetabular liner, across the full motion of sit-to-stand and step-up 
events. The results of the pre-operative analysis allow determination of cup 
orientation to an accuracy of 5 degrees of inclination and anteversion. 
 
The cup orientations displayed on the polar plots are in degrees of 
radiographic inclination and anteversion (Murray, 1993)1 referenced to 
the coronal plane when supine. The nine polar plots are equivalent to 
35-45 degrees of inclination and 20-30 degrees of anteversion, in the 
radiographic definitions referenced to the coronal plane when 
standing. 
Post-operative acetabular cup orientations are reported to an 
accuracy of ± 2 degrees. The representation of the combined implant 
and joint biomechanics on the acetabular liner is accurate to ± 0.5 
zones (which is equivalent to a 5% increment of the cup articular arc 
angle displayed on the report). 
The software version number and date of analysis can also be found 
on the report. If any assistance in interpreting the dynamic results is 
required, contact your Corin representative. 
System Requirements for Viewing Report 
The report is best viewed on a personal computer and requires Adobe 
Acrobat Reader and Flash Player software. 
The latest version of Adobe Acrobat Reader can be downloaded 
from www.get.adobe.com/reader/ 
The latest version of Adobe Flash Player can be downloaded 
from www.get.adobe.com/flashplayer/ 
Refer to www.adobe.com for minimum system requirements prior to 
installing software. 
Note that if viewing the dynamic report on a tablet or smart phone, 
Flash Player is not supported and the animation will not be displayed. 
Symbols Used 
Please contact your local Corin representative for the Product 
Information, Imaging Protocol or for further information. 
References 
1 Murray, D.W., The definition and measurement of acetabular orientation. 
The Journal of bone and joint surgery. British volume, 1993. 75(2):228-3 

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OPSTM Femoral Plan 
INSTRUCTIONS FOR USE 
www.coringroup.com 
OPS.customerservice@coringroup.com 
Manufacturer 
Optimized Ortho Pty Ltd 
17 Bridge Street Pymble 
NSW 2073 AUSTRALIA 
Authorised Representative 
Corin Limited 
The Corinium Centre 
Cirencester GL7 1YJ 
UNITED KINGDOM 
Intended Use 
The Optimized Positioning SystemTM (OPSTM) Femoral Plan is intended to 
assist with alignment of components during total hip arthroplasty. 
Product Description 
The OPSTM Femoral Plan is a custom made device used to assist the 
surgeon in determining a target osteotomy level. The Plan is used for 
operative planning, including implant selection, sizing and placement, 
quantifying changes to leg length and offset; and to create custom 
instruments or delivery specifications referencing the patient's anatomy. 
Materials 
OPSTM Femoral Plan is a custom made medical device and is presented 
in the form of a PDF report. 
Indications 
OPSTM Femoral Plan is intended to be used in conjunction with a total hip 
replacement system, for patients in which total joint arthroplasty is 
indicated. 
Contraindications 
OPSTM Femoral Plan is contraindicated for: 
 Patients in which total hip arthroplasty is contraindicated 
 Patients with significant orthopaedic deformities, e.g. fused knee, hip or 
ankle. 
 Patients who are unable to comply with imaging requirements 
 Patients currently receiving ionising radiation treatment or scans for 
other medical conditions 
 Any other implant system apart from the Corin Hip Product Range 
Conditions Affecting Performance, Side Effects and Adverse Effects 
The accuracy of the reported measurements and quality of the implant 
sizing and positioning is dependent on a number of factors: 
 Quality of CT scans – the prescribed Corin protocol has been designed 
to minimise the radiation dosage, while retaining sufficient detail in the 
structures for a patient specific three dimensional model of the joint. 
 Quality of X-rays – the protocol describes the key landmarks and 
functional positions required for patient specific analysis. 
 Provision of correct implant system details to ensure the correct 
implant geometry is imported into the model, and planned according to 
the surgeon’s surgical choices. 
Corin requires patient details and imaging for pre-operative analyses a 
minimum of five weeks prior to the surgery date. For requests submitted 
after this time, delivery of the plan cannot be guaranteed; however, all 
attempts will be made to accommodate requests at short notice. 
Incorrect use of the OPSTM Femoral Plan information may lead to an 
increased risk of poor functional outcomes including, but not limited to, limb 
length discrepancies, laxity or stiffness of the surrounding tissues, hip 
dislocation, pain, decreased range of motion and soft tissue impingement. 
Warnings and Precautions 
 
The information generated in the plan is a prediction of the 
implant sizing and subsequent leg length and offset changes as a 
result of the total joint replacement, derived from a three dimensional 
model constructed using the patient’s bone geometry. 
 
The information applies only to the patient identified, listed 
implant models and side of analysis. 
 
The results must not be used to alter the treatment regime of 
another patient. 
 
The results must not be used to treat a side other than what is 
specified in the analysis. 
 
The information applies only to specific implant system, sizes 
and positions and must not be used to draw conclusions outside the 
plan. 
Restrictions and Limitations on Use 
Use of information generated with OPSTM is restricted to registered 
orthopaedic surgeons. The information may not be used by implant 
manufacturers for unauthorised purposes, including evaluation and 
design of total joint replacement systems. 
The results of the patient specific analyses are based on radiographic 
imaging acquired on the date specified in the patient specific reports. 
Report Contents and Interpretation of Results 
The Femoral Plan is presented in PDF format. Corin takes all feasible 
measures to ensure that the report file is not corrupted and free from 
malware. In the event of a corrupted or infected file, do not attempt to 
open the report. Contact your local product representative or Corin for a 
replacement file. 
 
The reduced hip illustration represents the supine position from 
CT. 
 
Increase in Leg Length (LL) refers to the superior/inferior 
change in leg length from the pre-operative state. 
 
Increase in Offset is the overall change in offset measured along 
the femoral neck, perpendicular to the anatomical axis. 
 
Unless otherwise specified in the Warnings or Surgeon Notes, 
the stem and head are positioned to target the native, pre-diseased 
femoral head height. 
 
The acetabular shell is positioned 2mm off the true acetabular 
floor, unless stated otherwise in the Warnings or Surgeon Notes. 
 
The Greater Trochanter (GT) measurement refers to the height 
of the native head centre, relative to the superior tip of the greater 
trochanter. A positive value indicates the prosthetic head is superior, 
and a negative value indicates the prosthetic head is inferior to the GT. 
This measurement is taken parallel to the anatomic axis 
 
The Contralateral GT measurement shown in the Warnings 
section refers to the height of the contralateral head centre, relative to the 
superior tip of the contralateral greater trochanter. A positive value 
indicates the contralateral head centre is superior, and a negative value 
indicates the contralateral head centre is inferior to the GT. This 
measurement is taken parallel to the anatomical axis of the contralateral 
proximal femur. The measurement is only displayed if the difference from 
the GT measurement on the replaced side is >3mm. 
 
The anteversion of the native femur, posterior cortex and 
femoral stem are measured relative to the posterior condyles of the 
distal femur. 

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 The posterior cortex anteversion is defined by two landmarks on the posterior cortex at the level of the osteotomy. The landmarks are indicated on 
the front page of the report. 
 Where possible, the stem is orientated to reproduce the native femoral anteversion. 
 Native femoral offset is the perpendicular distance from the centre of the native femoral head to the anatomical axis. 
 The Lesser Trochanter (LT) measurement refers to the distance between the medial point of the osteotomy and a medial point along the femoral 
neck, which is level with the superior junction of the lesser trochanter. These landmarks are identified on page 2 of the report. 
 The osteotomy is at the level of the Hydroxyapatite (HA) for all uncemented stems, and at 45° at the level of the proximal mark for TaperFit stems. 
The angle will only be altered to avoid a step-cut if specified in the surgeon’s preferences; this will be indicated in the Warnings section. 
 A step-cut is defined by a cut that leaves a vertical face of bone at the anterior aspect of the GT of >5mm. 
 Unless otherwise specified by the orthopaedic surgeon, the preferred cup orientation is derived from a series of clinical preferences, captured for 
each surgeon user. 
The date of analysis is presented at the bottom of the report. If any assistance in interpreting the results is required, contact your local product 
representative or Corin. 
System Requirements for Viewing Report 
The report may be viewed on a personal computer, smart phone or tablet and requires Adobe Acrobat Reader. 
The latest version of Adobe Acrobat Reader can be downloaded from www.get.adobe.com/reader/ 
Refer to www.adobe.com for minimum system requirements prior to installing software. 
Symbols Used 
Caution 
Manufacturer 
Consult instructions 
for use 
Authorised 
Representative 
Do not re-use 
 
Please contact your local Corin representative for the Product Information, Imaging Protocol or for further information. 

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Manufacturer 
Optimized Ortho Pty Ltd 
17 Bridge Street Pymble 
NSW 2073 AUSTRALIA 
OPT-REC-RA-06 Rev 10 
 
OPSTM Delivery System 
INSTRUCTIONS 
FOR USE 
www.coringroup.com 
OPS.customerservice@coringroup.c
om 
Authorised Representative 
Corin Limited 
The Corinium Centre Cirencester GL7 1YJ UNITED 
KINGDOM 
Intended Use 
The Optimized Positioning SystemTM (OPSTM) Delivery System is intended to 
assist with alignment of components during total hip arthroplasty. 
Product Description 
The system consists of single use patient specific components and a set 
of reusable surgical instruments. 
- 
Acetabular cup orientation is assisted intraoperatively through 
the use of the custom made acetabular guide, custom made trial 
acetabulum (replica of the patient’s acetabulum, into which the 
guide fits) and reusable instruments (Class I). A custom made 
Patient Specific Visualisation (PSV) report provides the surgeon 
with a visual representation of the prescribed orientation and 
associated custom made patient specific guides. 
- 
Femoral neck osteotomy is assisted through the use of the  
custom made femoral osteotomy guide and custom made trial 
femoral head (replica of the patient’s femoral head, onto which 
the guide fits), if applicable. A custom made Femoral Plan 
enables the surgeon to prescribe the planned osteotomy level 
and a custom made PSV report provides the surgeon with a 
visual representation of the prescribed osteotomy and 
associated custom made patient specific guides. 
For each patient, one PSV report is provided to the surgeon 
preoperatively, and it may contain up to three 3D images, depending on 
the OPSTM products requested. 
For bilateral referrals, one PSV report is provided for each hip, each with 
their own prescribed component alignment and patient specific guide(s). 
OPSTM uses laser pointers to identify the orientation of the trial acetabular 
cup and patient specific acetabular guide and to align the final component. 
Materials 
Materials have been selected in accordance with ISO or ASTM standards 
and are biocompatible for surgically invasive short term use. OPSTM 
reusable instruments are primarily manufactured from 630 and 316 
stainless steel and polyoxymethylene (acetal) as per ASTM A564 / 
A564M-10, ASTM A967-05 and ASTM F1855. The custom made guides 
are manufactured from polyamide (nylon) as per ISO 16061(2008). 
System Requirements for Viewing PSV Report 
The PSV report may be viewed on a personal computer (requires Adobe 
Acrobat Reader software) or an Apple smart phone or tablet (requires 3D 
PDF Reader application). 

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The latest version of Adobe Acrobat Reader can be downloaded from 
www.get.adobe.com/reader/. 
Refer to www.adobe.com for minimum system requirements prior to 
installing software. 
For Apple smartphones or tablets, the latest version of 3D PDF Reader 
can be downloaded from your smart phone or tablet app store. 
Currently, the PSV report is not supported by applications for Android 
hardware. 
Indications 
OPSTM Delivery System is intended to be used in conjunction with a total 
hip replacement system, for patients in which total joint arthroplasty is 
indicated. 
Contraindications 
OPSTM Delivery System is contraindicated for: 
 
Patients in which total hip arthroplasty is contraindicated 
 
Patients with significant orthopaedic deformities (e.g. fused 
knee, hip or ankle), anatomical disruption or distortion of the pelvis 
 
Patients who are unable to comply with imaging requirements 
 
Patients currently receiving ionising radiation treatment or scans 
for other medical conditions 
 
Patients with insufficient bone structure or quality, which may 
not allow for rigid attachment of instruments 
 
Other disorders that affect pelvic anatomy and bony landmark 
recognition 
 
Patients with active infection 
 
Any other implant system apart from the Corin Hip Product 
Range 
Conditions Affecting Performance, Side Effects and Adverse Effects 
The accuracy of the reported measurements and quality of the implant 
sizing and positioning is dependent on a number of factors: 
 
Quality of CT scans – the prescribed Corin protocol has been 
designed to minimise the radiation dosage, while retaining sufficient 
detail in the structures for a patient specific three dimensional model of 
the joint. 
 
Provision of correct implant system details to ensure the correct 
implant geometry is imported into the model, and planned according to 
the surgeon’s surgical choices. 
Acetabular cup alignment is achieved using coincident laser beam 
projections on the operating wall or ceiling. This may be affected by: 
 
Operating theatre size 
 
Surgical equipment or structures obstructing the laser pointers 
The patient specific guides are designed to match the patient’s native 
bone. Errors within the operative technique and improper positioning or 
inadequate fixation of OPSTM components may result in: 
 
Limb length discrepancies 
 
Sub-optimal acetabular component orientation 
Adverse effects of any orthopaedic procedure may include infection, 
venous thrombosis, pulmonary embolism, cardiovascular disturbances, 
vascular or nerve injury, osteolysis, periarticular ossification, allergy, pain. 
Warnings and Precautions 
This system requires the use of Class 2 lasers. Do not stare directly into 
the laser beam as prolonged exposure may cause retinal damage. 
 

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Do not use if package
is damaged 
OPT-REC-RA-06 Rev 10 
 
The patient specific instruments within OPSTM are custom made and 
must only be used for the individual named on the packaging and on 
the part. These components are for single use only. Do not re-sterilise 
for reuse. 
The patient specific visualisation (PSV) and femoral plan reports are 
custom made and must only be used for the individual named on the 
report. These reports are for single use only. 
OPSTM has been designed for use with total hip replacement implant 
systems. Do not use OPSTM with incompatible implant systems as 
this may compromise the effectiveness of the total hip arthroplasty. 
Take care to select the appropriate instrument size for the patient. 
Correct instrument size will increase potential for success in the 
operative technique. 
Restrictions on Use 
Use of OPSTM is restricted to registered orthopaedic surgeons. This 
device should only be used in a sterile operating room of an accredited 
hospital. 
The patient specific guides, trial components, femoral plan and PSV 
report are custom made. As such they must only be used for the 
specified patient and referred hip (left or right), and must be used 
within their specified expiry date 
.Packaging 
All OPSTM parts are packaged in protective non-sterile packing. The 
patient specific instruments (guides and trials) must be removed from 
packaging and placed in an appropriate container or wrap for 
cleaning and sterilisation. Instruments that are provided in surgical 
trays may be steam autoclaved in these containers. 
Refer to full instructions for processing single use instruments and 
reprocessing reusable instruments. 
Handling and Storage 
OPSTM parts should be stored in their surgical trays when not in use 
to prevent damage to fragile instruments. 
Items should be stored in a limited access location, protected from 
sunlight, heat and moisture. Prior to sterilisation, inspect all 
instruments for visible damage and ensure that mating components 
can be assembled. Damaged instruments must not be used. Contact 
your local Corin representative for replacement parts. 
Refer to full instructions for processing single use instruments and 
reprocessing reusable instruments. 
Cleaning and Sterilisation 
All OPSTM parts are provided non-sterile and must be cleaned prior 
to sterilisation. The patient specific instruments must be removed 
from packaging for cleaning and sterilisation. 
Cleaning and disinfection is achieved through enzymatic soak and 
scrub followed by sonication. Automated cleaning using a 
washer/disinfector without manual pre-cleaning is not recommended. 
OPSTM instruments are intended for sterilisation by steam autoclave 
only. Other methods of sterilisation are not recommended. 
Instruments must be disassembled prior to cleaning, disinfection and 
sterilisation. It is important that the autoclave is maintained and 
calibrated so that the required temperatures and durations of 
sterilisation cycles are observed. 
NOTE: Laser pointers and batteries DO NOT undergo cleaning and 
sterilisation. 
Refer to full instructions for processing single use instruments and 
reprocessing reusable instruments. 
Operating Instructions 
Refer to OPSTM Surgical Technique for complete operating 
instructions. 
 
Symbols Used 
Fragile, handle with 
Catalogue number 
care 
Keep away from 
Batch code 
sunlight 
Caution 
Keep dry 
Consult instructions 
Date 
of 
manufacture 
for use 
Do not re-use 
Manufacturer 
Authorised Representative 
Date of expiry 
Please contact your local Corin representative for the 
Product Information, Surgical Technique, Reprocessing of 
Surgical Instruments, Cleaning and Sterilisation of Single-Use 
Instruments, Imaging Protocol or for further information. 
 

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24. 
APPENDIX 2. 
 
Symbios latest Version Dec 2016 
PELVIS 

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To include both iliac crests, entire pelvis, 
and proximal half of both femurs 
1.25mm slice thickness 
SINGLE HIP (in black box) with is the 
3rd series 
zoomed 
To include entire hip joint cavity and proximal 
half of single femur 
0.625mm slice thickness 
If scan request is for both hips, then another 
single hip series is required for the other hip 
BOTH KNEES 
To include both distal femoral condyles 
and proximal tibias (as far as tibial 
tubercles) 2.5mm slice thickness 
 
 
 
 
BOTH ANKLES & FEET 
To include both ankle joints and whole 
of feet 
2.5mm slice thickness                                           
This page is slightly different to the images on 
page 6 of this document. This page is provided to 
the radiographer to clarify certain aspects of the 
way the scan should be performed. The overall 
radiation dose of the CT is not affected by these 
modifications. 
 

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CT scan protocol 
 

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2 
As the accuracy of the HIP-PLAN® relies on the CT images that have been 
acquired, it is essential to follow as closely as possible the parameters 
described in this protocol, even though it might differ from hip imaging
protocols routinely used by your institution for diagnosis purpose. 
CT scan protocol 
Document objective 
This document specifies the protocol for the acquisition of CT 
images that are compatible with the HIP-PLAN®(1) 3D hip planning 
software. When combined with Symbios standard hip implants, the 
HIP-PLAN® allows orthopaedic surgeons to plan and reconstruct 
their patients with an increased accuracy (3)(4)(5) compared to 
conventional x-ray templating. Since 1989, Symbios also uses its 3D 
planning software to design custom-made hip prosthesis(6)(7)(8). 

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Patient’s position 
2 
3 
1 
The patient should be supine with the feet forward. 
The legs of the patient should be extended and aligned to the table axis. 
Slight hip flexion is permitted if the patient is experiencing pain. 
Check that the maximum course range of the table is sufficient to allow an 
examination starting from the top of the pelvis to the foot on the side to be 
operated. 
Important: It is essential that the patient is comfortably settled in order to 
prevent motion during the examination. Cushions and straps may be used to 
maintain the patient’s position. 
COURSE RANGE TO BE COVERED 
DURING ACQUISITION 
3 
 

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The protocol consists of a single acquisition composed of three separate 
spiral scans. The three reconstructed series should be axial and should 
provide slices that are adjacent. 
Image series 
Series 
Slice thickness 
and
spacing
Voltage 
(kV) 
Resolution 
(px) 
Reconstructed 
FOV  
(mm) 
PELVIS 
1.25 to 2 mm 
500 
512 x 512 
120 
RIGHT / LEFT 
0.5 to 0.8 mm 
200 
512 x 512 
120 
KNEES 
1.25 to 2 mm 
500 
512 x 512 
120 
ANKLES 
1.25 to 2 mm 
500 
512 x 512 
120 
SCOUTVIEW FACE 
SCOUTVIEW PROFIL 
Note: Both frontal and sagittal scout views (topograms) are required 
for the proper use of HIP-PLAN®, and they should be performed with the 
highest possible resolution. 
Scanner settings 
Acquisition mode 
Collimation and pitch parameters 
Spiral 
Define parameters as to allow a reconstruction with the lowest slice 
thickness as possible* (max. 0.8 mm) 
GE Healthcare 
Detail 
SIEMENS 
B31 
Reconstruction kernel 
for soft tissue** 
TOSHIBA 
FC13 
PHILIPS 
B 
Images resolution 
512 x 512 pixels 
Voltage 
120 [kV] 
Charge (mAs) 
Adapted to avoid artifacts according to the patient’s morphology 
(*) The minimum slice thickness can vary from a machine model to another according to the parameters that are  
set. However, the expected optimal thickness should be in between 0.5 mm and 0.8 mm. 
(**) For better imagery quality (noise reduction), the reconstruction filter for soft tissue is recommended.  
4 
 

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Right hip protocol 
Left hip protocol 
ANKLES 
KNEES 
PELVIS 
RIGHT HIP 
Adhere to the series as indicated above, particularly: 
Important: 
 PELVIS series: Include the iliac crests as well as the distal femoral isthmus. 
 HIPS series: Include the acetabulum as well as the distal femoral isthmus (including the 
false acetabulum in cases of congenital hip dysplasia). 
 KNEES series: Include the entire distal femoral epiphysis. 
 ANKLES series: Base the series around tibio-talar articulation. 
200 mm 
500 mm 
PELVIS 
500 mm 
200 mm 
LEFT HIP 
ANKLES 
KNEES 
5 
 

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6 
The most simple and effective method is to transfer the scanned images 
to Symbios via the Symbios Box. The Symbios Box is compatible with 
PACS/DICOM and is installed on the local area network (LAN) at your 
medical imaging center. This allows it to communicate with your PACS 
and to safely send
DICOM type images to Symbios over the internet
Safer 
The Symbios Box uses a highly sophisticated algorithm in order to encode 
the DICOM data during online transfer. Data confidentiality for your patients 
Simpler 
All you need is a regular internet browser (such as Chrome, Safari, Internet 
Explorer, Firefox, etc) to access the patient list and transfer the relevant 
your internet connection. 
Faster 
Because the data is sent directly via the internet, we receive the DICOM 
images at Symbios in less than 20 minutes*. We are therefore able to get a 
head start on designing custom-made implants for surgeons and their 
For more information about the Symbios Box, contact your Symbios 
representative. 
(*) Time taken to send images online may change subject to image size and the speed of 
Online (Symbios Box) 
Sending images to Symbios 
There are several methods available for sending scanned images to Symbios: 

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In person 
2 
or by post (CD-ROM) 
You can save the DICOM images onto a disk (CD-ROM or DVD-ROM] in 
uncompressed format and give them to your Symbios representative 
yourself or send them by post to the following address: 
Symbios 
Orthopédie 
SA 
Custom 
Hip 
Department 
Avenue des Sciences 1 
1400 
Yverdon-les-Bains 
Switzerland 
Radiation exposure 
As reported by Huppertz et al.(2], “a mean effective dose of 4.0 mSv (SD 
0.9 mSv] modeled by the BMI (p < 0.0001] was calculated” when using 
®
Data confidentiality 
Symbios undertakes to respect the confidentiality of the patient’s data, 
7 
 

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Symbios Orthopédie SA 
Avenue des Sciences 1 
1400 Yverdon-les-Bains 
Switzerland
T +41 24 424 26 26 
F +41 24 424 26 27 
Symbios UK Ltd Unit 2, 
Silverdown Office Park 
Fair Oak Close, Clyst 
Honiton Exeter, Devon 
EX5 2UX, United Kingdom 
T +44 1 392 365 884 F 
+44 1 392 365 885
 
(7) 
Three -dimensional custom-designed cementless 
femoral stem for osteoarthritis secondary to congen ital 
dislocation of the hip. Flecher X, Parratte S, Aubaniac JM, Argenson 
JN. Journal of Bone and Joint Surgery (British) 2007, vol. 89 -B, n°12. 
(8) 
Three-dimensional computed cementless custom femoral stems in
young patients: midterm follow-up. 
Wettstein M, Mouhsine E, Argenson JN, Rubin P, Aubaniac JM, Leyvraz PF. 
The information contained in this document is aimed exclusively at healthcare professionals, and has in no way been 
prepared for diagnostic or therapeutic purposes in a specific clinical case. It is therefore not a substitute for the opinion 
of a healthcare professional. 
The products presented in this document may only be used by specialist physicians or healthcare professionals, at their 
(6) Custom cementless stem improves hip function in young patients at 15 years 
follow-up. Flecher X, Pearce O, Parratte S, Aubaniac JM, Argenson JN. 
own responsibility. 
HIP-PLAN®, Custom HipTM and SYMBIOS® are registered trademarks of Symbios Orthopédie S.A, Switzerland. 
©Symbios Orthopédie S.A, Switzerland. All rights reserved. Ref: MKT.PROC0001V2.0.EN 
06/2014
References 
(1) 
Computed tomography f or preoperative planning in total h ip arthropla sty: what 
radiologists need to know. Huppertz A, Radmer S, Wagner M, Roessler T, Hamm B, Sparmann M.  
Skeletal Radiology 2014 (Epub). 
(2) 
Computed tomography for preoperative planning in minimal-invasive total hip arthroplasty: Radiation exposure 
and 
cost analysis. 
Huppertz A, Radmer S, Asbach P, Juran R, Schwenke C, Diederichs G, Hamm B, Sparmann M. European Journal of Radiology 2011, vol. 78, n°3. 
(3) 
Accuracy of reconstruction of the hip using computerised three-dimensional preoperative planning and 
cementless modular neck stem. 
Sariali E, Mouttet A, Pasquier G, Durante E, Catonne Y. 
Journal of Bone and Joint Surgery (British) 2009, vol. 91-B, n°3. 
(4) 
C o m p a r i s o n s  o f  p r e o p e r a t i v e  t h r e e - d i m e n s i o n a l  p l a n n i n g  a n d  s u r g i c a l  
r e c o n s t r u c t i o n  i n  p r i m a r y  c e m e n t l e s s  t o t a l  h i p  a r t h r o p l a s t y .  H a s s an i  H ,  C h e r i x  S ,  E k  E T ,  
R ü d ige r  H A.  
J o u rn a l o f  Ar t h r op l a s t y .  E pu b  8 J a n  20 14 .  
(5) 
Accuracy of the preoperative planning for cementless total hip arthroplasty. 
A randomized comparison between three-dimensional computerised planning and 
conventional templating. 
Sariali E, Mauprivez R, Khiami F, Pascal-Mousselard H, Catonne Y. 
Orthopaedics & Traumatology : Surgery & Research 2012, vol. 98, n°2.