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The Revision Hip & Knee Replacement: Evaluation of Clinical, Psychological and Surgical Outcomes Study has 3 main aims, which are to find out:

1.     What are the levels of function and satisfaction after revision hip and knee replacement surgery?

2.     What are the short-term complications from surgery?

3.     What are the longer-term outcomes from surgery?

The study will look back at data on patients who have had revision hip or knee replacement procedures in England since 2003. We will be analysing data from the National Joint Registry and NHS Digital. The datasets we will be using from NHS digital are:

  • Hospital Episode Statistics (HES)
  • Office for National Statistics mortality data (ONS)
  • National Patient Reported Outcome Measures (PROMS)

This study has been reviewed and approved by the London – Bromley Research Ethics Committee, reference 20/LO/0428.  

Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

The legal basis for the processing and storage of personal data for this study is that it is ‘a task in the public interest’ (article 6(1)(e)) and, that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (article 9 (2) (j), based on Article 89(1)).

The National Joint Registry holds information about patients who have undergone joint replacement and agreed to participation in their data audit. The NJR will send identifiers (study ID, NHS number, date of birth, gender and postcode) to NHS Digital.  NHS Digital will link this data to the HES, ONS and PROMS datasets.

The data that we receive and analyse will be identified by a trial number, and will not be identified by name, date of birth, NHS number or address. We will be provided with information on gender and month of death, if applicable. The information received from NHS Digital and the National Joint Registry will be imported into a database held securely by the University of Oxford and used solely for academic research purposes. Importantly, whilst the information received is specific to individuals, no individual person will be identifiable in any publication arising from this work..

Under Section 251 of the NHS Act 2006, we have permission to conduct this study without consent.

We have special permission to conduct the Revision Hip & Knee Replacement: Evaluation of Clinical, Psychological and Surgical Outcomes study without study-specific consent (i.e. link, transfer, process and analyse the data) from the Confidential Advisory Group. This permission is given under Section 251 of the National Health Service Act 2006 and its current regulations, the Health Service (Control of Patient Information Regulations 2002) (CAG reference number: 20/CAG/0044). 

How long we keep your data

The University of Oxford will retain the data until 30/09/2023 for the purposes of the study.

What to do next?

If you decide you do not want your data to be linked in this way you can withdraw from this follow-up, without affecting your current medical care. More information and the ability to opt out of data collection is available at https://www.nhs.uk/your-nhs-data-matters/. NHS Digital will not provide us with data for anyone who has withdrawn consent.

If you wish to withdraw your consent from the National Joint Registry then you may communicate this to them directly via telephone on 0845 345 9991 or email at enquiries@njrcentre.org.uk.

Data protection regulation provides you with control over your personal data and how it is used. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual-rights. If you would like to contact our data protection officer directly for more information about how we process and protect data collected for research, please email: data.protection@admin.ox.ac.uk.

If you have further questions or are not happy with the way your data has been handled, please contact the study team using the contact details below.  Alternatively, you can contact the study sponsor on 01865 616480 or ctrg@admin.ox.ac.uk.  You have the right to lodge a complaint with the Information Commmissioner’s Office (0303 123 1113 or www.ico.org.uk.

 

Principal Investigator: Professor Andrew Price

Telephone: 01865 223421