The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: a Mixed-methods Study
Conditions: Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Rehabilitation
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

 
POP-ACLR Study Protocol v1.2 10/Aug/2022 
IRAS Number: 315154 
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The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: 
a mixed-methods study 
The POP-ACLR Study  
Version and Date of 
Protocol: 
 
v1.2 10/Aug/2022 
Sponsor:  
University Hospitals of Derby and Burton NHS Foundation Trust 
Chief Investigator: 
Hayley Carter 
Local Study Reference: 
UHDB/2020/022 
IRAS Number: 
 
315154 
 
ISRCTN/ ClinicalTrials.gov 
number: 
 
This study will be registered with ISRCTN. 
Funder(s): 
This study is funded by a National Institute for Health Research 
(NIHR) Clinical Doctoral Research Fellowship.  
 
This protocol has regard for the HRA guidance 
 
 
 

 
 
 
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Confidentiality Statement 
 
This document contains confidential information that must not be disclosed to anyone other than 
the Sponsor, the Investigator Team, host NHS Trust, regulatory authorities, and members of the 
Research Ethics Committee. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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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 study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other 
regulatory requirement. 
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 investigation without the prior 
written consent of the Sponsor. 
I also confirm that I will make the findings of the study publicly available through publication 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 
in this protocol will be explained. 
 
Protocol version 1.2, 10.08.2022 authorisation signatures: 
 
Chief Investigator: 
Signature: 
 
 
Date: 10/08/2022 
 
 
Name: 
Hayley Carter 
 
 
 
 
 
 
SIGN

 
 
 
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KEY STUDY CONTACTS 
 
Chief Investigator: 
Hayley Carter 
Therapy Outpatients, Level 3 
Florence Nightingale Community Hospital 
London Road 
Derby 
DE1 2QY 
07585229838 
hayley.carter1@nhs.net / hayley.carter1@nottingham.ac.uk  
Co-Investigator(s): 
Professor Pip Logan 
Director of Research and Knowledge Exchange 
Room B108a Medical School 
Queens Medical Centre 
Nottingham 
NG7 2UH 
01158 230 235 
Pip.logan@nottingham.ac.uk  
 
Dr Fiona Moffatt 
Associate Professor 
Physiotherapy and Rehabilitation Sciences 
School of Health Sciences 
University of Nottingham 
Queen's Medical Centre 
Nottingham 
NG7 2HA 
+44 (0) 115 82 31788   
fiona.moffatt@nottingham.ac.uk 
 
Dr Paul Leighton 
Associate Professor in Applied Health Research 
Applied Health Research Building (Building 42) 
University Park 
Nottingham 
NG7 2HA 
+44 (0) 115 84 68629 
Paul.leighton@nottingham.ac.uk  
 
 
Dr Benjamin Smith 
AHP/HCS Clinical Academic Lead  
University Hospitals of Derby & Burton NHS Foundation Trust 
Therapy Outpatients, Level 3 
Florence Nightingale Community Hospital 
London Road 

 
 
 
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Derby 
DE1 2QY 
01332 254 631 
Benjamin.smith3@nhs.net  
 
Professor Kate Webster 
Professor and Head of Department Sport, Exercise and Nutrition 
Sciences 
Qual: BSc(Hons) PhD 
Employer: La Trobe University 
Address: Heath Sciences 3 Building 
Kingsbury Drive, Bundoora VIC 3086 Australia 
k.webster@latrobe.edu.au  
 
Professor David Beard  
Professor of Musculoskeletal and Surgical Science 
Surgical Intervention Trials Unit (SITU) 
Botnar Research Centre, NDORMS 
University of Oxford 
Windmill Road 
Oxford 
OX3 7LD 
01865 227 695 
david.beard@ndorms.ox.ac.uk  
Sponsor: 
University Hospitals of Derby & Burton NHS Foundation Trust 
Royal Derby Hospital 
Uttoxeter Road 
Derby, DE22 3NE 
01332 724639 
UHDB.sponsor@nhs.net  
Funder(s): 
Hayley Carter, Clinical Doctoral Research Fellow, NIHR302104, is 
funded by Health Education England (HEE) / NIHR for this 
research project.  
 

 
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STUDY SUMMARY 
 
Study Title: 
The POP-ACLR Study - The PreOperative Management of Patients 
Awaiting Anterior Cruciate Ligament Reconstruction: a mixed-
methods study 
Local Study Reference: 
UHDB/2020/022 
Study Design: 
A mixed-methods sequential exploratory design: 
Phase 1: Qualitative semi-structured individual interviews 
Phase 2: Nominal group technique consensus method 
Study Participants: 
Phase 1: Adults with an anterior cruciate ligament (ACL) rupture 
awaiting surgical intervention (anterior cruciate ligament 
reconstruction [ACLR]) 
Phase 2: Healthcare professionals with a special interest/expertise 
in ACL injuries, musculoskeletal outpatient therapy managers and 
patient representatives 
Planned Number of Sites: 
1 
Planned Sample Size: 
Phase 1: up to 36 participants (12 participants at three interview 
time points) 
Phase 2: up to 12 participants  
Participant Involvement  
Phase 1: One interview per participant lasting approximately 60 
minutes 
Phase 2:  
(a) Reading of pre-meeting material/voting on preliminary 
ideas (approximately 30 minutes) 
(b) Participation in a single face-to-face meetings lasting up to 
7.5 hours or in a series of shorter online meetings of 
approximately 2-3 hours 
Follow Up Duration: 
Phase 1: no follow-up required as each participant will be 
interviewed once 
Phase 2: all meetings/communication regarding the consensus 
meetings will take place over a 4 month period 
Planned Start Date: 
Phase 1 planned start date: 1st August 2022 
Phase 2 planned start date: 1st April 2023 
Planned Recruitment End 
Date: 
Phase 1: 31st December 2022 
Phase 2: 31st May 2023 
Planned Study End Date: 
Phase 1: 31st March 2023 
Phase 2: 30th September 2023 
Research Question/ Aims: 
Phase 1: To understand patients' lived experiences of the 
treatment pathway following a diagnosis of an ACL rupture and 
agreed surgical management with an ACLR 
Phase 2: To work with patients and stakeholders to develop a novel 
prehabilitation intervention for patients awaiting ACLR 
 

 
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FUNDING AND SUPPORT IN KIND 
 
Funder(s) 
Hayley Carter, Clinical Doctoral Research Fellow, 
NIHR302104, is funded by Health 
Education England (HEE) / NIHR for this research 
project.  
Financial and Non-Financial Support Given 
Research cost in full and salary costs as follows: 
Chief Investigator 1 WTE for 36 months 
 
Academic supervisory and mentor support from 
Professor Pip Logan, Dr Fiona Moffatt, Dr Paul 
Leighton, Dr Benjamin Smith, Professor David 
Beard and Professor Kate Webster.  
 

 
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ROLES & RESPONSIBILITIES 
 
Sponsor 
The Sponsor, University Hospitals of Derby & Burton NHS Foundation Trust, take on overall 
responsibility for appropriate arrangements being in place to set up, run and report the research 
project. The sponsor is not providing funds for this study, but has taken on responsibility for ensuring 
finances are in place to support the research.  
 
Funder 
This study is funded by a National Institute for Health Research (NIHR) Clinical Doctoral Research 
Fellowship. It is a contractual requirement that copies of all of project outputs are checked by the 
NIHR Academy (academy@nihr.ac.uk) a minimum of three working days before publication or 
presentation. 
 
Study Management Committees 
Trial Management Group (TMG) 
The trial management group will meet monthly to oversee the day-to-day management of the trial, 
including all aspects of the conduct of the trial. Any problems with study conduct will be raised and 
addressed during TMG meetings.  
Members: Hayley Carter, Pip Logan, Fiona Moffatt, Paul Leighton and Ben Smith. 
 
Trial Steering Committee (TSC) 
The trial steering committee will oversee and supervise the progress of the trial and ensure that it is 
being conducted according to the protocol and the applicable regulations. The TSC will meet every six 
months or more/less frequently if circumstances dictate during the study.  
Members: Hayley Carter, Pip Logan, Fiona Moffatt, Paul Leighton, Ben Smith, Kate Threapleton 
(sponsor representative), Michelle Slack (outpatient therapy manager) and Charlotte Dodsley and Josh 
McCallion (patient representatives). 
 
Patient and Public Involvement and Engagement (PPIE) Group 
Two patient representatives (named above) will be part of the TSC meeting every six months. There 
will also be regular meetings, every three months, with the wider PPIE group for updates on progress 
of the study and for advice from a patient and stakeholders' perspective. Any concerns raised will be 
addressed in the following TMG meeting. The PPIE group will also aid with the dissemination of the 
results from phase 1 and 2 to lay audiences and healthcare professionals by supporting press releases, 
social media posts and website content.  
 
Protocol Contributors 
A number of protocol contributors have been involved in the development of this protocol, these 
include: Hayley Carter, Pip Logan, Fiona Moffatt, Paul Leighton, Benjamin Smith, Kate Webster, David 
Beard, Kate Threapleton (sponsor representative), Charlotte Dodsley and Josh McCallion (patient 
representatives). Protocol contributors are responsible for inputting into the design of the study, 
ensuring that it is designed transparently and efficiently.   

 
 
 
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Contents 
SIGNATURE PAGE ................................................................................................................................... 3 
KEY STUDY CONTACTS ........................................................................................................................... 4 
STUDY SUMMARY .................................................................................................................................. 6 
FUNDING AND SUPPORT IN KIND .......................................................................................................... 7 
ROLES & RESPONSIBILITIES .................................................................................................................... 8 
LIST OF ABBREVIATIONS ...................................................................................................................... 11 
STUDY FLOW CHART ............................................................................................................................ 12 
1. 
BACKGROUND .............................................................................................................................. 14 
2. 
RATIONALE ................................................................................................................................... 14 
3. 
OBJECTIVES AND OUTCOME MEASURES/ ENDPOINTS ................................................................ 15 
3.1. 
Objectives ............................................................................................................................ 15 
3.2. 
Outcome .............................................................................................................................. 15 
4. 
STUDY DESIGN ............................................................................................................................. 16 
5. 
STUDY SETTING ............................................................................................................................ 16 
6. 
ELIGIBILITY CRITERIA .................................................................................................................... 16 
6.1. 
Inclusion Criteria .................................................................................................................. 16 
6.2. 
Exclusion Criteria ................................................................................................................. 16 
7. 
STUDY PROCEDURES .................................................................................................................... 17 
7.1. 
Recruitment ......................................................................................................................... 17 
7.1.1. 
Patient Identification ................................................................................................... 17 
7.1.2. 
Screening ...................................................................................................................... 17 
7.2. 
Consent ................................................................................................................................ 18 
7.3. 
Withdrawal Criteria .............................................................................................................. 18 
7.4. 
End of Study ......................................................................................................................... 18 
8. 
DATA HANDLING .......................................................................................................................... 18 
8.1. 
System and Compliance ....................................................................................................... 18 
8.2. 
Source Data .......................................................................................................................... 19 
8.3. 
Data Workflow ..................................................................................................................... 19 
8.4. 
Data Access and Security ..................................................................................................... 19 
8.5. 
Archiving .............................................................................................................................. 19 
9. 
STATISTICS AND DATA ANALYSIS ................................................................................................. 19 
9.1. 
Sample Size .......................................................................................................................... 19 
9.2. 
Data Analysis ........................................................................................................................ 20 
9.2.1. 
Summary of Baseline Data and Flow of Patients ......................................................... 20 
9.2.2. 
Outcome Analysis ........................................................................................................ 20 
9.3. 
Subgroup Analyses ............................................................................................................... 21 
9.4. 
Criteria for the Premature Termination of the Study .......................................................... 21 
10. 
MONITORING, AUDIT & INSPECTION ....................................................................................... 21 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS ....................................................................... 21 
11.1. 
Assessment and Management of Risk ............................................................................. 21 
11.2. 
Peer review ...................................................................................................................... 22 
11.3. 
Public and Patient Involvement ....................................................................................... 22 
11.4. 
Research Ethics Committee (REC) & Regulatory Considerations ..................................... 22 
11.5. 
Protocol Compliance / Non-compliance Reporting ......................................................... 22 
11.6. 
Notification of Serious Breaches to GCP and/or the Protocol ......................................... 23 
11.7. 
Data Protection and Patient Confidentiality .................................................................... 23 
11.8. 
Financial and Other Competing Interests for the Chief Investigator, Principal 
Investigators at Each Site and Committee Members for the Overall Study Management .............. 23 
11.9. 
Indemnity ......................................................................................................................... 23 

 
 
 
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11.10. 
Amendments .................................................................................................................... 23 
11.11. 
Access to Final Study Dataset .......................................................................................... 24 
12. 
DISSEMINATION POLICY ........................................................................................................... 24 
12.1. 
Dissemination Policy ........................................................................................................ 24 
12.2. 
Authorship Eligibility Guidelines and any Intended Use of Professional Writers ............ 24 
13. 
REFERENCES ............................................................................................................................. 24 
14. 
APPENDICES ............................................................................................................................. 27 
14.1. 
Appendix 2 – Amendment History ................................................................................... 27 
 
 

 
 
 
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LIST OF ABBREVIATIONS 
 
ACL 
ACLR 
AE 
ATOCP 
BASK 
BOA 
Anterior Cruciate Ligament 
Anterior Cruciate Ligament Reconstruction 
Adverse Event 
Association of Trauma and Orthopaedic Chartered Physiotherapists 
British Association for Surgery of the Knee 
British Orthopaedic Association 
CI 
Chief Investigator 
CRF 
Case Report Form 
DMEC 
Data Monitoring and Ethics Committee 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice  
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation of technical requirements for 
registration of pharmaceuticals for human use. 
ISF 
Investigator Site File 
ISRCTN 
International Standard Randomised Controlled Trials  
NHS R&D 
National Health Service Research & Development 
PI 
Principal Investigator 
PIC 
Participant Identification Centre 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomised Control Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure  
TMG 
Trial Management Group 
TSC 
Trial Steering Committee 
TMF 
UHDB 
Trial Master File 
University Hospitals of Derby and Burton NHS Foundation Trust 
 

 
 
 
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STUDY FLOW CHART: mixed-methods sequential exploratory design 
 
Eligibility screening 
(orthopaedic and 
physiotherapy 
waiting/clinic lists)
Eligibility screening 
(professional networks 
and social media)
Consent
Qualitative 
interview
Qualitative analysis
Eligibility screening
(professional networks 
and social media)
Dissemination
Consent
Pre-elicitation 
material 
distributed
Consensus 
meetings
POP-ACLR 
intervention 
developed
Dissemination
Future feasibility 
study
Phase 1
Phase 2
Withdrew
Excluded

 
 
 
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STUDY TIMELINE: starting from 1st April 2022 
 
 
 
Year 1 
2022/23
Year 2
2023
Apr May Jun
Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun
Jul Aug Sept
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Planning
Phase 1
12 months
Submit & await ethical 
approval
Recruitment
Interviews
Qualitative analysis
Phase 2
6 months
Recruitment
Distribution of pre-elicitation 
material
Consensus meetings
POP-ACLR intervention 
finalised
Trial management group
Trial steering committee
PPIE meetings
Write up
Dissemination

 
 
 
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STUDY PROTOCOL 
 
1. 
BACKGROUND 
 
The anterior cruciate ligament (ACL) is the most commonly injured ligament in the knee with an 
estimated 200,000 injuries occurring each year in the US (UK data unavailable).1 Surgery is currently 
standard treatment for this injury and aims to help patients return to work and preinjury levels of 
physical activity.2,3 There are an estimated 14,000 surgeries performed each year in England.4 
 
Prior to COVID-19, waiting times for anterior cruciate ligament reconstruction (ACLR) were between 
4 and 12 months,1 however this has increased in the past two years due to the cancellation of elective 
procedures during the COVID-19 pandemic.5 Whilst awaiting surgery, preoperative rehabilitation (also 
termed 'prehabilitation') has been identified as an important component to help patients prepare, 
both physically and mentally, for surgery and postoperative rehabilitation.6–8 However, current 
practice for this stage is varied and it is unknown what proportion of patients receive prehabilitation.9 
 
Patients have high expectations of ACL surgery10 and most set a goal of returning to work and their 
preinjury level of sport/activity.11–13 However, this outcome is frequently documented to be sub-
optimal with only 24% returning to preinjury levels of activity at 1 year.14 Despite the high prevalence 
of ACL injuries amongst the physically active population, the qualitative evidence base accounting in-
depth experiences remains limited. No study to date has looked to understand: (1) patients' lived 
experiences of ACL injury, rehabilitation and returning to physical activity following ACLR (2) sources 
and consistency of healthcare advice prior to surgery and (3) patients' involvement in, and views of 
prehabilitation. This remains an important gap in the evidence base. 
 
ACL injuries, surgery and rehabilitation are costly to the NHS, costing upwards of £63 million each 
year.1 With a lack of clinical guidelines or standard treatment pathway to inform clinicians, the 
effectiveness of care provided by the NHS during the lengthy preoperative period is questionable. 
Ensuring the patient journey is successful is therefore hugely important. Optimising treatment prior 
to ACLR could improve patient outcomes and ensure greater value for money.  
 
2. 
RATIONALE 
 
There are no established guidelines to inform the preoperative management of patients awaiting ACLR 
and currently, there is a lack of evidence demonstrating its effectiveness.15 A recent systematic review 
found only three, low quality, randomised controlled trials which explored treatment effectiveness.15 
The results concluded that prehabilitation including strength, balance and perturbation training, when 
compared to no prehabilitation, offers small benefits (established through effect size calculations) to 
quadriceps strength and single leg hop distance (a commonly used postoperative functional test) three 
months after ACLR.  
 
In addition, there are currently no prehabilitation programmes that include psychological elements 
and no studies evaluating the effect of prehabilitation on psychosocial outcomes; paradoxically, these 
are key components highlighted in the literature to predict postoperative outcomes and influence 
return to preinjury levels of activity.2,16–18 It has further been highlighted that an individual's response 

 
 
 
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to injury, surgery and rehabilitation is an important consideration in ACL treatment and that the role 
of psychological factors has been undervalued.17,19–24 
 
At present, the evidence does not provide consensus for clinical practice. The evidence gaps support 
the need to explore patients experiences further and develop an intervention that is implementable 
within an NHS setting to support patients prior to ACLR. 
 
3. 
OBJECTIVES AND OUTCOME MEASURES/ ENDPOINTS 
 
3.1. 
Objectives 
Aim 
This research aims to: 
(1) Understand patients' lived experiences of the treatment pathway following a diagnosis of 
an ACL rupture and agreed surgical management. 
(2) Develop a prehabilitation intervention for use with patients awaiting anterior cruciate 
ligament reconstruction (ACLR). 
 
This project underpins future work for a study that will understand feasibility, acceptability and 
tolerability of the prehabilitation intervention with respect to participants and clinicians in an NHS 
setting. 
 
Objectives 
Phase 1: 
1. To interview approximately 36 participants at three time points: 
(1) 12 participants up to 3 months before surgery 
(2) 12 participants 3 months after surgery 
(3) 12 participants 12 months after surgery 
2. To explore patients' lived experiences of ACL injury, rehabilitation and returning to physical 
activity following ACLR 
3. To explore patients' involvement in and views of prehabilitation 
4. To understand patients' sources and consistency of healthcare advice prior to surgery 
 
Phase 2: 
1. To develop a prehabilitation intervention for use with patient awaiting ACLR using the nominal 
group technique 
 
3.2. 
Outcome 
 
Phase 1: lived experiences of the treatment pathway following a diagnosis of an ACL rupture and 
agreed surgical management 
 
Phase 2: development of a novel intervention for use with patients awaiting ACLR to be implemented 
into clinical practice as part of a feasibility study 
 

 
 
 
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4. 
STUDY DESIGN 
 
A mixed-methods sequential exploratory design utilising semi-structured qualitative interviews and 
nominal group technique consensus method. 
 
5. 
STUDY SETTING 
 
Both phases will be run at the Florence Nightingale Community Hospital within the University 
Hospitals of Derby and Burton NHS Foundation Trust (UHDB). 
 
Phase 1: interviews will be carried out at the hospital, virtually or at a location preferred by the 
participant.  
 
Phase 2: consensus meetings will take place in-person or virtually dependent upon participants 
geographical location range and preference. 
 
6. 
ELIGIBILITY CRITERIA 
6.1. 
Inclusion Criteria 
Phase 1: 
(1) ≥ 18-years-old 
(2) Patient who is awaiting or has previously had an ACLR in the NHS 
 
Phase 2: 
 
(1) ≥ 18-years-old 
(2) Participants will be in one of the following categories: 
(a) Healthcare professional in the NHS with a special interest/expertise in treating ACL 
injuries (must have treated a patient prior to or post ACLR within the last 2 years) 
(b) Therapy manager of an NHS musculoskeletal outpatient therapy department 
 
 
(c) Patient who is awaiting or has previously had an ACLR in the NHS 
 
6.2. 
Exclusion Criteria 
Phase 1: 
(1) Concomitant injuries requiring surgical intervention that will significantly alter the 
postoperative rehabilitation protocol e.g. meniscal repair requiring a non-weight bearing 
period 
(2) Previous knee surgery to the affected limb  
(3) Co-existing injuries requiring surgical intervention impacting on the individual's 
participation in pre- or post-operative rehabilitation 
(4) Pregnancy 
 
Phase 2: 
(1) Anyone with a recognised conflict of interest 
 
 
 

 
 
 
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7. 
STUDY PROCEDURES 
 
7.1. 
Recruitment 
 
7.1.1. 
Patient Identification  
 
Phase 1: Patients will be purposively sampled to obtain a varied sample in relation to patient 
characteristics, physical activity (running, cutting/pivoting sports, level of physical activity 
participation) and those who received prehabilitation or not. The sampling framework will be 
responsive to data emerging from previous interviews to allow for further exploration of points of 
interest. It is anticipated that the characteristics of participants at the three different time point will 
not be identical, and will complement each other aiming for a wide variety in patient characteristics. 
 
The recruitment of patients has been discussed with surgeons and physiotherapists at UHDB. The 
surgeon's secretary will provide a list of patients awaiting surgery and orthopaedic postoperative 
clinical review to the physiotherapy team. The physiotherapy team will also identify appropriate 
patients on their clinical caseload. A member of the physiotherapy team will contact patients 
regarding the study to confirm eligibility, provide study information if appropriate and gain consent 
for the researcher to make contact to discuss the study. If a participant interested in the study does 
not read or speak English, relevant study material will be translated into their preferred language and 
communicated with facilitation of a translator. This will be arranged following normal procedures of 
the in-house translation service in the Physiotherapy Department at the University Hospitals of Derby 
and Burton NHS Foundation Trust.   
 
The researcher will also advertise the study to potential participants through posters in physiotherapy 
and orthopaedic clinics and to colleagues through professional and special interest networks (such as 
Association of Trauma and Orthopaedic Chartered Physiotherapists [ATOCP], British Association for 
Surgery of the Knee [BASK] and British Orthopaedic Association [BOA]) via a letter/email and/or 
poster, to allow potential participants to contact the researcher directly. These networks will also be 
asked to share the material to promote the study on their social media platforms.  
 
Phase 2: participants will be recruited via professional and special interest networks (ATOCP, BASK, 
BOA) via a letter/email and/or poster. These networks will also be asked to share the material to 
promote the study on their social media platforms. There will be at least one therapist and therapy 
manager recruited from UHDB, as this will be the primary site for feasibility testing of the intervention 
in a future study.    
 
A social media account for the study (Twitter: @POP_ACLR) will also advertise the recruitment 
material for phase 1 and 2.  
 
7.1.2. 
Screening 
 
Phase 1: eligibility screening will take place on initial identification/contact with potential participants. 
If deemed eligible they will be provided with the participant information sheet (PIS) and consent form. 
No further screening will be completed.  
 
Phase 2: eligibility screening will take place by potential participants on response to study 
advertisement. On making contact with the research team, eligibility will be confirmed prior to gaining 
consent for participation. No further screening will be necessary.  

 
 
 
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7.2. 
Consent 
 
Patients meeting the eligibility criteria for phase 1 and 2, will be invited to participate in the study and 
provided with the participant information sheets and consent documents relevant to the phase of the 
study. This will include contact information for the CI to give participants the opportunity to ask further 
questions if needed. Consent will be gained as per Good Clinical Practice guidelines. This will include 
an explanation of the study purpose, what participation in the study involves including its benefits, 
risks, burdens and rights to withdraw at any time.  
 
Informed consent must be obtained prior to the participant undergoing procedures that are 
specifically for the purposes of the study. 
 
The Chief Investigator (CI) retains overall responsibility for the informed consent of participants and 
must ensure that any person delegated responsibility to participate in the informed consent process 
is duly authorised, trained and competent according to the REC approved protocol and applicable 
guidelines and regulations. 
 
7.3. 
Withdrawal Criteria 
 
Participants will be free to withdraw at any time from phase 1 or 2 without this affecting their future 
care (applicable to patients in phase 1 and 2). Participants will be made aware (via the information 
sheet and consent form) that should they withdraw, the data collected to the point of withdrawal may 
not be able to be erased and may still be used in the final analysis due to blinding of data.  
 
7.4. 
End of Study 
 
The end of study will be defined as when all data has been received and queries resolved. The CI will 
notify the Sponsor, participating sites and REC within 90 days of the end of study. The clinical study 
report will be written within 12 months of the end of study.  
 
8. 
DATA HANDLING 
 
8.1. 
System and Compliance 
 
Data will be collected using a mix of paper and electronic methods. Where possible a patient ID 
number will be used rather than identifiable information. Data from paper forms will be transcribed 
into an electronic database in Microsoft Word or Excel stored on OneDrive. Microsoft OneDrive is an 
ISO 27001 information security management compliant service that allows secure and controlled 
sharing of data amongst the research team. Data will also be backed up to secure servers at UHDB. 
Paper hard copies will be stored in the relevant Investigator Site Files. Study documentation will be 
stored securely (i.e. cupboards, shelves or filing cabinets with restricted access e.g. within a locked 
office) in the Physiotherapy Department at Florence Nightingale Community Hospital to maintain 
participant confidentiality and study data integrity.  
 

 
 
 
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Qualitative data will be organised and managed using NVivo software. Audio recordings and 
transcriptions will be stored on OneDrive and backed up to secure servers at UHDB. An NHS-approved 
third-party transcription service will be used that complies with data security regulations. Audio 
recordings will be uploaded to OneDrive and deleted from the original recording device. Recordings 
kept on OneDrive will be archived as outlined in section 8.5. 
 
8.2. 
Source Data 
 
Data 
Source 
Location of Original 
Consent (qualitative) 
ACL-POP Qualitative Consent 
Form 
Trial site for paper copies / 
OneDrive for electronic copies 
Consent (consensus meetings) 
ACL-POP Consensus Consent 
Form 
Trial site for paper copies / 
OneDrive for electronic copies 
Field notes 
CI notes from interviews and 
consensus meetings 
Trial site for paper copies / 
OneDrive for electronic copies 
Interview recordings 
Audio dictation files 
OneDrive 
Interview transcripts 
Word documents 
OneDrive 
Consensus meeting recordings 
Audio dictation files 
OneDrive 
Consensus 
meetings 
voting 
(quantitative) 
Word documents 
OneDrive 
 
 
8.3. 
Data Workflow 
 
The CI will maintain the electronic study files. This will be hosted on OneDrive and backed up to secure 
servers at UHDB 
 
8.4. 
Data Access and Security 
 
The CI will control access to the electronic database. Direct access will be granted to authorised 
representatives from the Sponsor, host institution and the regulatory authorities to permit study-
related monitoring, audits and inspections. 
 
8.5. 
Archiving 
 
At the end of the study, following completion of the end of study report, UHDB will securely archive 
all centrally held study related documentation for a minimum of 5 years. At the end of the defined 
archive period arrangements for confidential destruction will be made. It is the responsibility of the CI 
to ensure that data and all essential documents relating to the study are retained securely for a 
minimum of 5 years after the end of study, and in accordance with national legislation. All archived 
documents must continue to be available for inspection by appropriate authorities upon request.  
 
9. 
STATISTICS AND DATA ANALYSIS 
 
9.1. 
Sample Size  
 

 
 
 
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Phase 1: up to 36 participants will be recruited 
Phase 2: up to 12 participants will be recruited 
 
9.2. 
Data Analysis 
 
9.2.1. 
Summary of Baseline Data and Flow of Patients 
 
Descriptive statistics will be presented to summarize baseline variables of participants. The 
categorical variables (e.g. gender, ethnicity) will be reported with frequencies & percentages. 
 
9.2.2. 
Outcome Analysis 
 
Phase 1: qualitative data analysis 
An inductive approach will be used to allow flexibility to generate data that reflects the experiences 
of participants. The CI will keep a reflexive journal to document initial thoughts after each interview 
and on initial reading of the transcripts. Data familiarisation will be established by reading and re-
reading transcripts to allow for data immersion and generation of preliminary ideas. The CI will be 
responsible for coding the dataset with a sample (25%) of the scripts peer-coded by another member 
of the supervisory team. Codes will then be compared and grouped into themes and sub-themes. The 
derived themes and sub-themes will be discussed during academic supervisory and TMG meetings. 
Only those involved in coding the dataset will have access to the raw data. Only samples of scripts will 
be taken to TMG meetings which will remain anonymous. Themes will then be reviewed to ensure 
they accurately represent the raw and coded data.  
 
The results of phase 1 will contribute to the design of the intervention using an adapted nominal group 
technique. This will involve the use of a 'pre-elicitation technique'25 where participants will be 
provided with a summary of the themes generated from the interviews prior to the first consensus 
meeting to help inform their ideas and decision making process. This may also include preliminary 
voting on key intervention components to be discussed at the first meeting.  
 
Phase 2: nominal group technique  
Consensus group meetings will be held with healthcare professionals with a special interest/expertise 
in ACL injuries (e.g. physiotherapists, occupational therapists, surgeons), physiotherapy managers and 
patient representatives to discuss and agree the key components of the prehabilitation intervention.  
 
Consensus group meetings will take place in a single, face-to-face meeting (lasting up to a full day of 
7.5 hours) or in a series of shorter online meetings – based on participants preference. They will aim 
to gain consensus about key components of the intervention for patients who have been diagnosed 
with an ACL rupture and listed for surgery. Components may include (1) referral guidance for 
orthopaedic colleagues (including timeline and reasonings for a referral to physiotherapy), (2) aims 
and content of physiotherapy sessions, (3) outcome measures to be used and (4) patient education. 
 
Participants will rank ideas pertaining to each intervention component, it is common amongst the 
literature that five ideas are ranked 26–28 with the larger number reflecting greater importance. In line 
with consensus recommendations,29,30 the threshold will be set at ≥70%. If consensus cannot be 
reached, points of contention will be discussed at TMG meetings. Components of the intervention will 

 
 
 
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be finalised with the patient representatives and presented to the patient and stakeholder group at 
informal coffee mornings. 
 
Data analysis for both phases will be performed by the CI with supervision and checking by the 
academic supervisory team. 
 
9.3. 
Subgroup Analyses 
 
Subgroup analysis will be considered in phase 1 to compare codes, themes and sub-themes between 
participants who: 
(1) received treatment at UHDB and those treated outside of the Trust (if recruited)   
(2) engaged in prehabilitation and those who didn't 
(3) were interviewed at the three different time points 
 
9.4. 
Criteria for the Premature Termination of the Study 
 
The Sponsor may suspend or prematurely terminate either the entire study for significant reasons that 
must be documented (e.g. an unacceptable risk to participants or serious repeated deviations from 
the protocol/ regulations). If this occurs the Sponsor shall justify its decision in writing and will 
promptly inform any relevant parties (i.e. participants, investigators REC, regulatory bodies).  
 
10. 
MONITORING, AUDIT & INSPECTION 
 
The Investigator(s) must ensure that source documents and other documentation for this study are 
made available to study monitors, the REC or regulatory authority inspectors. Authorised 
representatives of the Sponsor may visit the participating sites to conduct audits/ inspections. No 
further monitoring above this is planned. 
 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
11.1. 
Assessment and Management of Risk 
 
The main risks associated with participation in the qualitative interviews is the potential to elicit 
feelings of anxiety and distress when discussing personal experiences, confusion of the research 
process with a therapeutic encounter and the identification of need for further help. The interviewer 
is a trained physiotherapist with four years’ experience treating this patient group. They have the 
appropriate training and knowledge to discuss any potential negative experiences mentioned in the 
interview and to signpost the participants to appropriate departments/organisations should they 
deem it necessary. They are trained in Safeguarding Level 3, with an awareness of appropriate 
procedures to follow. The CI will be responsible for assessing and managing risk, reporting this to the 
TMG and TSC as appropriate.  
 
There are no known risks to participation in phase 2.  
 
 

 
 
 
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11.2. 
Peer review 
 
This study has been peer reviewed as part of the NIHR Clinical Doctoral Research Fellowship 
application process. 
 
11.3. 
Public and Patient Involvement 
 
A PPIE group was formed prior to the application for funding to assist with the project design. The 
patient representatives and wider PPIE group will continue to be involved in: 
• 
TSC meetings 
• 
Reviewing patient/public facing information 
• 
Reviewing project timelines and discussing/interpreting early results 
• 
Dissemination 
 
11.4. 
Research Ethics Committee (REC) & Regulatory Considerations 
 
The study will be conducted in compliance with the approved protocol and the Declaration of Helsinki. 
The protocol and all related documentation (e.g. informed consent form, participant information 
sheet, questionnaires) have been reviewed and received approval by a Research Ethics Committee 
(REC). The investigator will not begin any participant activities until approval from the HRA and REC 
has been obtained and documented. All documentation and correspondence must be retained in the 
trial master file/investigator site file. Substantial amendments that require HRA and REC (where 
applicable) review will not be implemented until the HRA and REC grants a favourable opinion (with 
the exception of those necessary to reduce immediate risk to participants).  
 
It is the responsibility of the CI to ensure that an annual progress report (APR) is submitted to the REC 
within 30 days of the anniversary date on which the favourable opinion was given, annually until the 
study is declared ended. The CI is also responsible for notifying the REC of the end of study (see Section 
6.9) within 90 days. Within one year of the end of study, the CI will submit a final report with the 
results, including any publications/abstracts to the REC. 
 
Before any site can enroll a patient into the study confirmation of capacity must be sought from the 
site’s research and development (R&D) department. In addition for any amendment that will 
potentially affect the site’s permission, the research team must confirm with the site’s R&D 
department that permission is ongoing (Section 11.10). 
 
11.5. 
Protocol Compliance / Non-compliance Reporting  
 
The chief investigator is responsible for ensuring that the study is conducted in accordance with the 
procedures described in this protocol. Prospective, planned deviations and/or waivers to the protocol 
are not acceptable, however accidental protocol deviations (non-compliances) may happen and as 
such these must be recorded. Non-compliances should be recorded in the CRF and/or a non-
compliance log kept in the ISF.  All non-compliances should be reviewed and assessed by the PI (or 
appropriately delegated individual) to determine if they meet the criteria of a “serious breach” 
(Section 12.6). Non-compliances which are found to frequently recur are not acceptable, will require 
immediate action, and could potentially be classified as a serious breach. 

 
 
 
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11.6. 
Notification of Serious Breaches to GCP and/or the Protocol 
 
A “serious breach” is a departure from the protocol, Sponsor procedures (i.e. SOPs), or regulatory 
requirements which is likely to effect to a significant degree – 
(a) The safety or physical or mental integrity of the subjects of the study; or 
(b) The scientific value of the study. 
If the PI (or delegate) is unsure if a non-compliance meets these criteria, they should consult the 
Sponsor for further guidance.  
If a serious breach is identified the investigator should notify the Sponsor immediately (i.e. within 1 
working day) using the ‘Non-CTIMP Notification of a Serious Breach’ form. The report will be reviewed 
by the Sponsor and CI, and where appropriate, the Sponsor will notify the REC within 7 calendar days 
of being made aware of the breach.  
 
11.7. 
Data Protection and Patient Confidentiality 
 
The study will be conducted in accordance with the Data Protection Act 2018. The investigator must 
ensure that participant’s anonymity is maintained throughout the study and following completion of 
the study. Participants will be identified on all study specific documents (except for the informed 
consent form and enrolment log) only by the participants study specific identifier (and initials if 
deemed necessary). This identifier will be recorded on documents and the database. The Investigator 
Site File will hold an enrolment log detailing the study specific identifier alongside the names of all 
participants enrolled in the study.  
All documents will be stored securely with access restricted to study staff and authorised personnel.  
 
Hayley Carter (CI) will act as the custodian of the data generated in the study. 
 
11.8. 
Financial and Other Competing Interests for the Chief Investigator, Principal 
Investigators at Each Site and Committee Members for the Overall Study 
Management 
 
Hayley Carter, Clinical Doctoral Research Fellow, NIHR302104, is funded by Health Education England 
(HEE) / NIHR for this research project. The views expressed are those of the author(s) and not 
necessarily those of the NIHR, NHS or the UK Department of Health and Social Care. 
 
11.9. 
Indemnity 
 
As UHDB is acting as the research Sponsor for this study, NHS indemnity applies. NHS indemnity 
provides cover for legal liabilities where the NHS has a duty of care. Non-negligent harm is not covered 
by the NHS indemnity scheme. UHDB, therefore, cannot agree in advance to pay compensation in 
these circumstances. In exceptional circumstances an ex-gratia payment may be offered. 
 
 
11.10. 
Amendments 
 

 
 
 
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If changes to the study are required these must be discussed with the Sponsor, who is responsible for 
deciding if an amendment is required and if it should be deemed substantial or non-substantial. 
Substantial amendments will be submitted to the relevant regulatory bodies (REC, HRA) for review 
and approval. The amendments will only be implemented after approval and a favourable opinion has 
been obtained. Non-substantial amendments will be submitted to the HRA for their approval/ 
acknowledgment. Amendments will not be implemented until all relevant approvals are in place. 
 
11.11. 
Access to Final Study Dataset 
 
Access to the final study dataset will be limited to the research team and sponsor. 
 
12. 
DISSEMINATION POLICY 
 
12.1. 
Dissemination Policy 
 
Data will be disseminated in the following ways: 
• 
Publication in peer-reviewed open-access journals 
• 
Presentation of national/international physiotherapy and orthopaedic conferences such as 
those run by Chartered Society of Physiotherapy (Physiotherapy UK), British Orthopaedic 
Association (BOA) and British Association for Surgery of the Knee (BASK) 
• 
Newsletter for participants/public contributors  
• 
In-service training sessions at the University Hospitals of Derby and Burton NHS Foundation 
Trust 
• 
Social media and trial website 
 
12.2. 
Authorship Eligibility Guidelines and any Intended Use of Professional Writers 
  
It is expected that any first drafts of publications for academic journals and the final study report will 
be authored by the named co-investigators. Final authorship shall be in accordance with the 
International Committee of Journal Medical Editors (ICJME) guidance.31 
 
13. 
REFERENCES 
 
1. 
Beard, D. The ACL SNNAP Trial: ACL surgery necessity in non acute patients. ISRCTN: 
10110685 Clinical Trials Gov: NCT02980367 (2017) 
doi:https://doi.org/10.1186/ISRCTN10110685. 
2. 
Ardern, C. L., Taylor, N. F., Feller, J. A., Whitehead, T. S. & Webster, K. E. Psychological 
responses matter in returning to preinjury level of sport after anterior cruciate ligament 
reconstruction surgery. Am. J. Sports Med. 41, 1549–1558 (2013). 
3. 
Shea, K. G. et al. The American Academy of Orthopaedic Surgeons evidence-based guideline 
on management of anterior cruciate ligament injuries. J. Bone Joint Surg. Am. 97, 672–674 
(2015). 
4. 
Jameson, S. S. et al. Complications following anterior cruciate ligament reconstruction in the 
English NHS. Knee 19, 14–19 (2012). 
5. 
Hampton, B. M. et al. The orthopaedic waiting list crisis. https://doi.org/10.1302/2633-
1462.27.BJO-2021-0044.R1 2, 530–534 (2021). 
6. 
Everhart, J. S., Best, T. M. & Flanigan, D. C. Psychological predictors of anterior cruciate 
ligament reconstruction outcomes: a systematic review. Knee Surgery, Sports Traumatology, 

 
 
 
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Arthroscopy vol. 23 752–762 (2015). 
7. 
Wilk, K. E. & Arrigo, C. A. Preoperative Phase in the Rehabilitation of the Patient Undergoing 
Anterior Cruciate Ligament Reconstruction. Oper. Tech. Sports Med. 24, 12–20 (2016). 
8. 
Gokeler, A., Dingenen, B., Mouton, C. & Seil, R. Clinical course and recommendations for 
patients after anterior cruciate ligament injury and subsequent reconstruction: A narrative 
review. EFORT Open Rev. 2, 410–420 (2017). 
9. 
Carter, H. M., Webster, K. E. & Smith, B. E. Current preoperative physiotherapy management 
strategies for patients awaiting Anterior Cruciate Ligament Reconstruction (ACLR): A 
worldwide survey of physiotherapy practice. Knee 28, 300–310 (2021). 
10. 
Feucht, M. J. et al. Patient expectations of primary and revision anterior cruciate ligament 
reconstruction. Knee Surgery, Sport. Traumatol. Arthrosc. 24, 201–207 (2016). 
11. 
Ardern, C. L. et al. 2016 Consensus statement on return to sport from the First World 
Congress in Sports Physical Therapy, Bern. Br. J. Sports Med. 50, 853–864 (2016). 
12. 
Lynch, A. D. et al. Consensus criteria for defining ‘successful outcome’ after ACL injury and 
reconstruction: A Delaware-Oslo ACL cohort investigation. Br. J. Sports Med. 49, 335–342 
(2015). 
13. 
Feller, J. A. & Webster, K. E. Return to sport following anterior cruciate ligament 
reconstruction. International Orthopaedics vol. 37 285–290 (2013). 
14. 
Webster, K. E. & Feller, J. A. Expectations for Return to Preinjury Sport Before and After 
Anterior Cruciate Ligament Reconstruction. Am. J. Sports Med. 47, 578–583 (2019). 
15. 
Carter, H. M., Littlewood, C., Webster, K. E. & Smith, B. E. The effectiveness of preoperative 
rehabilitation programmes on postoperative outcomes following anterior cruciate ligament 
(ACL) reconstruction: A systematic review. BMC Musculoskelet. Disord. 21, 1–13 (2020). 
16. 
Filbay, S. R. & Grindem, H. Evidence-based recommendations for the management of anterior 
cruciate ligament (ACL) rupture. Best Practice and Research: Clinical Rheumatology vol. 33 
33–47 (2019). 
17. 
Webster, K. E., Feller, J. A. & Lambros, C. Development and preliminary validation of a scale 
to measure the psychological impact of returning to sport following anterior cruciate 
ligament reconstruction surgery. Phys. Ther. Sport 9, 9–15 (2008). 
18. 
Ardern, C. L. et al. The impact of psychological readiness to return to sport and recreational 
activities after anterior cruciate ligament reconstruction. Br. J. Sports Med. 48, 1613–1619 
(2014). 
19. 
Kvist, J., Ek, A., Sporrstedt, K. & Good, L. Fear of re-injury: A hindrance for returning to sports 
after anterior cruciate ligament reconstruction. Knee Surgery, Sport. Traumatol. Arthrosc. 13, 
393–397 (2005). 
20. 
Langford, J. L., Webster, K. E. & Feller, J. A. A prospective longitudinal study to assess 
psychological changes following anterior cruciate ligament reconstruction surgery. Br. J. 
Sports Med. 43, 377–381 (2009). 
21. 
Ardern, C. L., Taylor, N. F., Feller, J. A. & Webster, K. E. A systematic review of the 
psychological factors associated with returning to sport following injury. British Journal of 
Sports Medicine vol. 47 1120–1126 (2013). 
22. 
Ardern, C. L., Webster, K. E., Taylor, N. F. & Feller, J. A. Return to sport following anterior 
cruciate ligament reconstruction surgery: A systematic review and meta-analysis of the state 
of play. British Journal of Sports Medicine vol. 45 596–606 (2011). 
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Brand, E. & Nyland, J. Patient outcomes following anterior cruciate ligament reconstruction: 
The influence of psychological factors. Orthopedics vol. 32 335 (2009). 
24. 
McCullough, K. A. et al. Return to high school- and college-level football after anterior 
cruciate ligament reconstruction: A Multicenter Orthopaedic Outcomes Network (MOON) 
cohort study. Am. J. Sports Med. 40, 2523–2529 (2012). 
25. 
Gonzales, C. K. & Leroy, G. Eliciting user requirements using Appreciative inquiry. Empir. 
Softw. Eng. 16, 733–772 (2011). 
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A Guide to Nominal Group and Delphi Processes. Glenview, Scott, Foresman Co. (1975) 
doi:10.1177/002188637601200414. 
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McMillan, S. S. et al. Using the Nominal Group Technique: how to analyse across multiple 
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28. 
Dening, K. H., Jones, L. & Sampson, E. L. Preferences for end-of-life care: A nominal group 
study of people with dementia and their family carers. Palliat. Med. 27, 409–417 (2013). 
29. 
Tugwell, P. et al. OMERACT: An international initiative to improve outcome measurement in 
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Trials 13, 132 (2012). 
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http://www.icmje.org/icmje-recommendations.pdf (2009). 
 

 
 
 
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14. 
APPENDICES 
 
14.1. 
Appendix 2 – Amendment History 
 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
0 
V1.0 
31 May 2022 
Hayley Carter 
Initial document 
1 
v1.1 
20 July 2022 
Hayley Carter 
Further detail added regarding 
risk management, destruction 
and transcription of interview 
recordings 
2 
v1.2 
10 Aug 2022 
Hayley Carter 
Pre-operative interview window 
extended from 2 weeks before 
surgery to 3 months before 
surgery