This study will investigate whether a non-surgical treatment option will provide patients with comparable ankle function and quality of life to those treated with surgery.
Both treatments are used across the NHS currently and are not new or experimental.
In this study we use a process called randomisation, which means you cannot choose which treatment you have.
If you decide you would like to be involved in the study you will be asked to sign a consent form.
The only additional commitment we would ask of you would be to fill out a questionnaire at the start of treatment and on three occasions during your recovery.
As you have broken your ankle you are eligible to be a part of this study.
This study is expected to last 8 years. At the end of the study we will publish the findings in medical journals and at medical conferences.
Want to find out more? Take a look at our FAQs below…
Why do patients participate in studies?
Three patients who have participated in clinical research share why they took part and how they benefited, as part of NIHR’s I Am Research campaign 2018.
Why are you doing this study?
This trial will investigate whether the non-surgical treatment option will provide patients with comparable ankle function and quality of life to those treated with surgery.
Why have I been asked to take part?
Who is funding the study?
The study is supported by a grant from The National Institute for Health Research.
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project reference NIHR127273). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Who is running the study?
The FAME study is the work of Bone Specialists across the UK, with research support from the University of Oxford. The University of Oxford is the lead centre for the study, and the day-to-day running of the study is being completed by Oxford Trauma, a research group of the Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences.
Who has reviewed this study?
This study has been reviewed by the East Midlands – Leicester Central Research Ethics Committee and approval was given on 3 September 2019.
How have patients and public been involved in this study?
We value the patient perspective which has been key in the development of this research. Our patient representative has reviewed this patient information and all FAME patient facing documents. Participants’ views will continue to be represented throughout the study. Additionally, the oversight committees, that will regularly review the study progress, include at least one patient representative who will be involved in discussion and decision making throughout the duration of the study.
If you would like to know more about getting involved in research as a patient or member of the public, please see https://www.nihr.ac.uk/patients-carers-and-the-public/.
Can I download a copy of the study information?
Yes, you can download the patient information by clicking this link: Patient Information Sheet v3.0 27 August 2020.
What if new information becomes available?
Sometimes during the course of a research study, new information becomes available about the treatment that is being studied. If this happens, the research team will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw, we will encourage you to discuss your continued care with your doctor. If you decide to continue in the study you will be asked to sign an updated consent form.
What happens if something goes wrong?
The University of Oxford is the Sponsor for the study and has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. If you wish to discuss any aspect of the way in which you have been approached or treated during the course of this study, you should contact Associate Professor Xavier Griffin who is the overall lead of this study on 01865 223116; or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 616480 or email firstname.lastname@example.org. NHS indemnity covers any other treatment with which you are provided.
What will happen to the information I give?
Your personal details will be held by the research team at University of Oxford. We will remove any details that would identify you personally (such as your name, date of birth, etc.) from your answers to our questions and no individual results will be published.
We will share limited personal information (your NHS number, gender, date of birth and postcode) with appropriate organisations (including, but not limited to, NHS Digital, National Services Scotland (NSS), Office of National Statistics, Clinical Practice Research Datalink) in order to link your study data to specific records related to the research held in other databases. This will allow bodies such as NHS Digital, National Services Scotland (NSS), Office of National Statistics, Clinical Practice Research Datalink to provide us with a temporary linkage dataset containing your medical data with identifying information removed, that will only identify you by your study ID. Although it is extremely unlikely to affect you individually or as a result of your ankle injury, over the time period of this study it is possible that some participants may die. We plan to collect this more sensitive information just so that we can perform the analyses more accurately. Once the linkage is complete, the temporary linkage dataset will be destroyed. All information that is collected during the course of the research will be used and stored in accordance with the most up to date data protection legislation.
What happens to my personal data?
Any data from which you can be identified, such as your name, gender, date of birth, or data concerning your health, is known as personal data. The University of Oxford, as sponsor, is the data controller. This means that the University of Oxford is responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible. The University of Oxford is working with other NHS and research organisations to deliver this study:
Members of the study team from these organisations will only have access to de-identified and aggregated data for the purposes of contributing to the oversight, analysis and reporting of the study.
We will keep any research documents with identifiable information about you for 12 months after the study has finished. Your contact details will be kept until the long-term follow up is completed (5 years after treatment). We will store the anonymised research data securely at the University of Oxford for a minimum of 5 years after publication of the results of the study. You have the right to access, change or remove your contact details. Your rights to access, change or remove your NHS number (or equivalent), gender, date of birth and postcode, and data concerning your health, are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate, and restricting its use would seriously impair its use for research purposes.
Your personal data will only be used as we have explained on this page, and research is a task that we perform in the public interest. If you are concerned about how your personal data is being used, please contact the study team using the contact details on the Contact page.
Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/research-data.
The lawful basis for the processing of your personal data is governed by the General Data Protection Regulation (GDPR) Articles 6 & 9. The University of Oxford will not transfer your personal data to any third countries or international organisations.
Where can I find contact details for the FAME study?
Contact details are on our Contact page.
Can I download a copy of the rehabilitation booklet?
Yes, you can download the rehabilitation booklet by clicking this link: Next steps in your recovery after a broken ankle v2.0 06 May 2020.
What will happen to the results?
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