Additional Information

Part 1: INFORMATION ABOUT TAKING PART IN OUR STUDY

Why have I been asked to take part?

We are a team of researchers investigating which of the hip implants currently available on the NHS are best for patients under 70 years of age. You have been sent this information because you are under 70 years old and listed to undergo a planned hip replacement due to osteoarthritis. We have developed a short video about the study, which you can view here .  

What is the purpose of the study?

There are currently three main types of hip implants being used for patients undergoing a total hip replacement in the UK: cemented, uncemented or hybrid implants. It is unclear which type is best for patients under 70. With this study, we want to find out which of the implant types is better for patients under 70 by looking at whether patients need a second surgery to fix the implant (also known as revision surgery). This will give us more information about the long-term effectiveness of the implant. We will also look at how each type of implant affects patient’s quality of life and how much each implant type costs the NHS. 

This study is part of a wider programme of research projects. To find out more about the wider HIPPY programme, please visit the HIPPY programme website. 

What happens during hip replacement surgery?

When doing a hip replacement, there are two main parts that need to be attached to your bone. There is the acetabular component (the cup) and there is the femoral component (the stem). The cup is fixed in the pelvis and the stem looks like a long spike and this goes down the inside of the femoral (thigh) bone. We put a ball (called the head) inside the cup to form a movable hip joint.  Both the cup and the stem can be attached to the bone in the body, with cement or without cement. 

When we use cement, the cement is mixed in theatre to make a putty. We put the cement into the bone and then we push the components into it. The components and the cement then go inside the bone. After a few minutes, the cement hardens and holds the components in place. 

When attaching the implant without cement, the hole made in the bone is slightly smaller than the components, and the stem and cup are pressed to fit into the bone. With time, the bone cells in your body bond with the implant.  

There are three options (implants) surgeons can use to attach the two components (the stem and the cup) to your body:

These three implants are all used routinely within the NHS. Currently, for most hip replacement surgery, the surgeon will decide which type of implant to use. The type of implant that is used can depend on what is routinely stocked at a particular hospital or which procedures the respective surgeon is more familiar with.  

There is good evidence that the cemented option is highly effective and the most cost-effective option in patients over the age of 70. The aim of HIPPY is to see whether the fully cemented option, the fully uncemented option or the hybrid option works best in patients under 70.   

What will I have to do if I take part?

You will be given time to go over the study information. If you are interested in taking part, a member of your local research team will talk to you about this study. They will explain the study in more detail and answer any questions you may have.  

Taking part in research is voluntary; it is up to you to decide whether you would like to join the study. You are free to stop taking part at any time, and you do not have to give any reason for your decision. The standard of care you receive will not be affected if you decide not to take part. 

Consent 

You will need to take the time to read and understand what the study would involve for you. You can speak to the research nurses or doctors who will answer any questions you may have. If you decide you would like to take part in the study you will be asked to provide your written agreement to do so, which we call ‘informed consent’. 

Option to help us improve information about the HIPPY study (selected sites only)

The HIPPY research team wants to make sure that information about the HIPPY study is clear and easy to understand for people who are thinking about taking part. To help us to do this we’d like the staff member who introduces the study to you, to audio-record their conversation with you. 

We are also inviting some patients to talk with a researcher from the team to understand what you think about the HIPPY study, the information you have been given, and whether you have any further questions. We call this a “short interview”. It should take around 25 minutes and can be done over the telephone at a time that’s convenient for you. 

By listening to the recorded conversations and interviews with people about their experience of being invited to take part in the HIPPY study, we can make improvements to how the information about the study is presented and communicated. 

Taking part in this part of the study is completely optional. You are free to take part in one, both, or none of these activities. You can still take part in the main study even if ou don’t want to have the conversation about the study recorded or take part in the short interview.  

If you are happy to help us to understand and improve how information about the HIPPY study is provided, we will ask you to sign a consent form which shows you agree to take part in the above activities. If you are selected, a researcher will contact you to arrange the short telephone interview. 

If you are happy to help us to understand and improve how information about the HIPPY study is provided, we will ask you to sign a consent form which shows you agree to take part in the above activities. If you are selected, a researcher will contact you to arrange the short telephone interview.

Randomisation and Implant type 

If you agree to take part, the type of hip implant you receive will be chosen at random. Some surgeons only use two of the three types of implant, so the implant type will be chosen between two options or three, depending on who your surgeon is. Once you’ve been assigned to a group, your surgeon will be able to tell you which implant you will be receiving.  

Questionnaires 

As part of the study, we will ask you to complete some questionnaires:

  • Before your surgery (after you have been assigned to a group), 
  • Approximately 6 months after your operation, 
  • Every 12 months until 10 years after your operation. 

These questionnaires will give us information about your general health and your hip. For example, we will ask you how you are feeling, what activities you are able to perform and how much pain you might be feeling. The study aims to be paperless, so please complete the questionnaires electronically if you can. If you prefer you can complete it over the phone with a member of the research team.  

In the 6-month questionnaire, you will be asked if anyone has helped you after surgery. If they have, we will ask you to please give your carer/helper a link to a questionnaire for them to complete.. Their questionnaire will ask for information about activities they may have missed due to supporting someone undergoing total hip replacement surgery. This includes time off work and leisure activities, as well as any additional personal expenses. This will help us to understand the impact of total hip replacement surgery on the health and wellbeing of helpers / carers as well. 

As part of the yearly questionnaires, we will ask you about any further hip surgeries you have received. If needed, we may contact you to request further information.  

During the study follow up period we may send you reminders about the questionnaires via SMS text message. The text message will come from the Bristol Trials Centre. To send you SMS text messages we may need to share your phone number with  a University of Bristol approved third party provider. This data will be stored and processed within the UK. 

Data collection 

If you agree to take part in the HIPPY study, we will collect some information about you from your medical records. We will also ask your permission to collect some information about you from some healthcare databases.  

NHS England Hospital Episode Statistics (HES) and SAIL (Secure Anonymised Information Linkage Databank) collect information from all hospitals on behalf of the UK Government. This information is routinely collected by the NHS whenever you have hospital treatment. We are interested in information about any hospital stays you may have after joining the study for at least ten years after your surgery 

We will also obtain information relating to your hip surgery (including any further operations you may have) and mortality data from the National Joint Registry (NJR), the Outcome Registries Platform (ORP) and the Office of National Statistics (ONS). Most patients in HIPPY are expected to survive more than ten years following their operation, but we need to collect information on mortality to fully understand what happens to all patients.  

We will also collect information from the national Patient Reported Outcome Measures (PROMs) database. These are national programmes in England and Wales that will send questionnaires to you, usually before and after surgery. The questionnaires aim to find out about your care, experience and health status.   

To obtain the information from NHS England, SAIL, NJR, ONS, OPR and the national PROMs databases, we need your permission to share your full name, sex, NHS number, postcode and date of birth with them. They will use this information to link to records they hold about you.  

We will also ask your permission to continue to collect data from these healthcare registries beyond the initial 10 years, if further funding is secured by the research team, to continue to evaluate the long-term effectiveness of the hip implants. 

Overview of timing of study activities

What alternatives are there to taking part? 

If you do not want to take part in the main study, you can still help by giving us permission to collect data from your medical records and healthcare databases. We will ask for your permission to access your medical records but your surgeon will decide which implant you will have and you will not be asked to complete any questionnaires. 

If you decide not to take part in the any part of the research study, or if you are not suitable (eligible) for the study, then you will receive the usual care provided at your local hospital. 

What are the possible benefits of taking part?

We cannot promise that the study will help you, but we hope that the results from this study may help the NHS and improve the management of future patients undergoing hip replacements. 

If you take part, you may also have more contact with your local research team and you can let them know if you have any problems. 

What are the possible risks and disadvantages of taking part in the study?

There should be no additional risk if you agree to take part in this study as all three implant types are regularly used in the NHS and none are new or experimental. Your surgeon will explain the risks and benefits of the surgery itself.  

If you agree to take part in the study, you will be asked to spend time completing questionnaires.  

How long will I be in the study? 

The study will run for at least 10 years.  

We will ask you to complete questionnaires for up to 10 years from the time you join the study.  

With your permission, data collection from your medical records and healthcare registries may continue beyond 10 years to continue to evaluate the long-term effectiveness of the hip implants, but you will not need to do anything.  

What will happen if I do not want to carry on with the study?

If you agree to take part, you can change your mind at any time and stop all or just some parts of the study. Your usual care won’t be affected if you stop or change how much you take part. This will be discussed with you when you contact us. If you decide to stop being part of the study before your surgery, you will receive the normal method of treatment at your hospital or by your surgeon.  

You won’t have to explain to anyone why you want to stop. However, if you do feel able to tell us about your experience in the study, it can help the research team learn and improve what we do.  

You can contact your study surgeon or nurse if you are finding it hard to take part. They may be able to help you.  

If you stop taking part, we will keep information about you that we have already collected and include it in the study results. This makes the study results more reliable.  

You can request these changes by email, writing, by telephone, or in person by contacting your local research team or the Central Study Team using the contact details here. 

What will happen to the results of the research study?

The results of the research will not be known until after the end of the trial (about 15 years after the start of the study). The study results may be reported in medical journals or presented at meetings, but your identity will never be disclosed. We will ask you if you would like to receive a summary of the results by email after the research has finished. You can also sign up to receive a copy of the results on the study website. You will still be able to have a copy of the study results if you stop taking part in the study.  

What if relevant new information becomes available? 

Sometimes we get new information about the treatment being studied. If this happens, your clinical care team will tell you and discuss whether you should continue in the study.  

What if there is a problem?

If you have any concerns or questions about this study, please contact the research team listed below. If you have concerns about the way you have been treated during the study or wish to make a formal complaint, you can contact your local Patient Advice and Liaison Service (PALS). Contact details for your local service are listed here. 

We have no reason to believe that you will be placed at any greater risk to your health by taking part in this study. However, if something goes wrong and you are harmed during the study there are no special compensation arrangements.  

If anything goes wrong because of taking part in the study due to negligence, the NHS trust responsible will compensate you. Negligence includes, for example, if injury was caused by a deviation from the study protocol by a researcher. The normal NHS complaints mechanisms will still be available to you. 

Who is organising and funding the research?

The research is sponsored by the NHS and will be carried out jointly by the University of Bristol and North Bristol NHS Trust. The research is being organised and run on their behalf by the Bristol Trials Centre (BTC), University of Bristol. The National Institute for Health and Care Research (NIHR) have provided the funding for the study. 

Part 2: INFORMATION ABOUT HOW WE WILL USE YOUR DATA

What information will you collect about me and how will it be used?

North Bristol NHS Trust is the sponsor for this study based in the United Kingdom and the central study team is based at the Bristol Trials Centre, University of Bristol. Together we will use information from you and your medical records to undertake this study and will act as joint data controllers for this study. This means that we are responsible for looking after your information and using it properly. The University of Bristol and North Bristol NHS Trust will process your personal data on behalf of the data controllers, in their role as data processors.  

Before consent we will ask for a copy of your email address (for contact purposes), your age, gender, ethnicity and your postcode. Your age, gender, ethnicity and postcode will be used to determine if the study is being inclusive to participants of all backgrounds. This information will not be used to identify you. 

We will need to use information from you and your medical records for this research study.  Your local research team will collect this information in accordance with our instructions. 

This information may include your:

  • Initials
  • NHS number
  • Name
  • Contact details (including postcode, email address and contact number)
  • Date of birth
  • Email address (if available)

This information will be used to allow us to keep in touch with you during the study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Research staff will use this information to do the research or check your records to make sure that the research is being done properly. 

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. 

We will keep all information about you safe and secure. 

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. Study documents will be stored in secure storage during the conduct of the study and for at least 10 years after the end of the study. 

Your medical records and study files may be inspected by individuals from the regulatory authorities, the sponsor organisation or other NHS Trusts as required to ensure the study is being conducted to all legal standards and to check the accuracy of the research study.  

With your consent, your GP will also be informed that you are taking part in the study.  Your GP may be asked to provide information from your GP medical records for the research. 

Sealed Envelope™ are the company who provide the randomisation software which helps to enable the process of allocation. We will provide Sealed Envelope™ with relevant information about you (your code number for the study, where you are having your surgery and who your surgeon is) to enable their system to allocate you to a group (i.e. cemented, uncemented or hybrid implant). We will not give Sealed Envelope™ personal information that could identify you.  

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep any information about you that we already have. If you choose to stop taking part in the study, we would like to continue collecting information about your health from your central NHS records. If you do not want this to happen, tell us and we will stop. To safeguard your rights, we will use the minimum personally identifiable information possible.  

We need to manage your information in specific ways for the research to be reliable and accurate. This means that we will not be able to let you see or change the data we hold about you.  

If you agree to take part in this study, you will have the option for your data to be saved for potential use for future research being run in this organisation and in other organisations. The data will be stored in a University of Bristol secure repository and made available only to researchers who meet the criteria for access to confidential data. Researchers from outside the HIPPY team will not be able to identify you from this information.  

Where can I find out more about how my information is used?

You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/ or

  • By asking one of the research team
  • Our leaflet available from www.nbt.nhs.uk/PatientResearchdata
  • By ringing us on +44(0)117 45 54799

You can find contact details for your local research team here.

 

 


Central Study Team


HIPPY Central Study Team

Bristol Trials Centre (BTC)


University of Bristol


1-5 Whiteladies Road, Bristol, BS8 1NU

Tel: +44(0)117 45 54799

Email: hippy-trial@bristol.ac.uk

 

This study is funded by the NIHR Programme Grant for Applied Research (NIHR203671).
The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

 

 

HIPPY Supplementary Participant Information | V2.0 | 17Jul24