Incidence of peri-prosthetic fracture with the cemented collarless polished taper stem

Nottingham University Hospitals NHS Trust (NUH) requires access to NHS England data for the purpose of the following research project:

“Incidence of peri-prosthetic fracture with the cemented collarless polished taper stem following total hip replacement (THR)”.

The following is a summary of the aims of the research project provided by Nottingham University Hospitals NHS Trust:

“Periprosthetic fractures are a serious complication of total hip replacement (THR). Recent publications have suggested a higher prevalence of periprosthetic fractures with the collarless polished taper stem compared to other polished taper stem designs and a higher revision rate for periprosthetic fractures in the UK National Joint Registry. A small audit performed at Nottingham Teaching Hospitals found that its experience was that the periprosthetic fracture rate in the collarless taper stem was in line with the periprosthetic fracture rate in other polished taper stem designs. The aim of this study is to identify if any of the patients who have had a collarless taper stem total hip replacement in Nottingham University Hospitals have suffered a periprosthetic fracture after surgery. Our large cohort size would be the largest in the published literature for this specific stem, and so the aim of the study is to give an answer to the question of periprosthetic fractures around this specific collarless tapered stem”.

The following NHS England Data will be accessed:

• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary to provide information to identify any periprosthetic fractures in the patient cohort, in order to give a clear periprosthetic fracture rate. It will also allow for the assessment of these fracture patterns to see if there is any correlation.

The level of the data will be identifiable because Nottingham University Hospitals NHS Trust holds the identifying details. However, the data that will be disseminated under this data sharing agreement (DSA) will contain no identifying details.

The Data will be minimised as follows:

• Limited to a study cohort identified by Nottingham University Hospitals NHS Trust, approximately 2900 patients, to include any patient who received a collarless tapered stem as part of their total hip replacement at Nottingham University Hospitals, who then suffered a fracture around their total hip replacement.

• Limited to data between 2009 and latest available at the time of the dissemination (expected in 2024), as fracture can occur anytime following a THR, 2009 is the earliest date that this medical device was first fitted.

• Limited to conditions relevant to the study identified by specific ICD or OPCS codes.

Nottingham University Hospitals NHS Trust is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes, or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users, and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by Zimmer Biomet. The funding is specifically for the study described. Funding is in place until completion of the study.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Data will be accessed by an individual with a letter of release for Nottingham University Hospitals NHS Trust. The individual’s substantive employer is the University Hospitals of Derby and Burton NHS Foundation Trust and under their contract, it states their commencement date as 16/02/2023 – 31/03/2025 unless terminated earlier in accordance with the contractual controls specified. The individual is permitted to work specifically on the study described above and must report to the Chief Investigator who is a substantive employee of Nottingham University Hospitals NHS Trust, for all supervisory requirements, they must adhere to all organisational policies and controls during this time.

A Public and Patient Involvement and Engagement group was not used to help refine the purpose of the research, as Nottingham University Hospitals NHS Trust felt this was not appropriate for this type of retrospective study of data, however after further advice from the Confidentiality Advice Team (CAT) the applicant confirmed they are working with the patient and public involvement team at NUH and are advertising the opportunity for PPI through posters and through formal discussions about the study through their Research Hub website: https://www.nottinghamresearch.org/ and through the NIHR People in Research website, to further build their evidence of meaningful engagement with patients, service users and the public.

Nottingham University Hospitals NHS Trust will transfer data to NHS England. The data will consist of identifying details specifically NHS Number, Date of Birth, Postcode, and a unique person ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC dataset to Nottingham University Hospitals NHS Trust. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record-level data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at Nottingham University Hospitals NHS Trust.

The Data will be accessed onsite at the premises of Nottingham University Hospitals NHS Trust only.

The Data will not leave England at any time.

Data will be accessed by an individual with a letter of release at Nottingham University Hospitals NHS Trust. The individual will act as an agent of Nottingham University Hospitals NHS Trust at all times under supervision from employees of Nottingham University Hospitals NHS Trust. Aside from this individual, access is restricted to employees or agents of Nottingham University Hospitals NHS Trust. who have authorisation from the Chief Investigator.

Zimmer Biotec is not permitted to access the Data, Zimmer Biomet will not suppress or alter any outcomes of the study.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the Nottingham University Hospitals NHS Trust will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer-reviewed journals

• Presentations at specific conferences.

Following the conclusion of this study the aim is to disseminate the results to the orthopaedic and scientific community. This will be done via numerous channels including presentations (local, national, and international) and peer-reviewed journals. It may have an impact on policy decisions as the decision to continue to use this particular implant may be affected by the results of this study.

The target date for the production of outputs is 2024.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Industry newsletters

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, and local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment, and experience of healthcare users relevant to the subject matter of the study.

The use of the data could:

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions.

• inform planning health services and programmes, for example, to improve equity of access, experience, and outcomes.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice that need to be addressed.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The findings of this project may have a significant effect on the health of patients. The choice of implant in a total hip replacement is a crucial decision in the treatment algorithm, the finding of this study may play a significant role in the choice of implants for a total hip replacement, both nationally and internationally.

Periprosthetic fracture is a significant injury and has huge consequences. The information gained from this study may help identify the risks of fracture around this particular hip replacement stem, which in turn may help with the care of all patients requiring a hip replacement.

The benefit of this study may include clearly answering the question as to whether this particular implant is associated with periprosthetic fractures. The dissemination of the findings of this study will follow a programme of local and regional presentations, followed by peer-reviewed journal publications and national/international presentations.

The impact of this study may be profound, the collarless tapered stem is the 2nd most-used implant for total hip replacements in the UK, averaging around 7000 per year. Therefore the outcome of this study may affect a huge number of patients and clinicians. The benefits are difficult to quantify, especially as the findings of the study are pending the outcome of the data collection and processing. The aim is to have the information ready for dissemination by the end of 2024.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations, and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Not stated in the register.