Investigating the risks and outcomes of surgery for fracture-related infection and bone infection after fracture fixation

The Data will be used for the purpose of a research project: Investigating the risks and outcomes of surgery for fracture-related infection and bone infection after fracture fixation

The project investigates the incidence, risk factors, healthcare utilisation, and outcomes associated with fracture-related infection (FRI) and osteomyelitis (OM) managed within the NHS in England.

FRI and osteomyelitis are serious musculoskeletal infections associated with repeated surgery, prolonged hospitalisation, long-term antibiotic treatment, disability, reduced quality of life, and substantial NHS cost. Despite their clinical importance, there is limited national-level evidence quantifying;

1. The population incidence of surgically managed FRI and osteomyelitis

2. Patient characteristics associated with increased risk

3. Patterns of reoperation and healthcare utilisation

4. Variation in management and outcomes across NHS providers

This study directly addresses priorities identified through the James Lind Alliance (JLA) Priority Setting Partnership for complex fractures. In particular, it contributes evidence toward answering two nationally identified unanswered questions:

1.What is the best way to reduce the risk of infection after complex fractures?

2. Is it possible to determine which patients will develop complications and poor long-term outcomes after complex fractures?

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry-leading analytics tools.

NHS England will provide access to the relevant records from the HES APC and Civil Registration Deaths to UoO via NHS England Secure Data Environment (SDE). The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be minimised by the applicant as follows:

• All patients aged ≥16 years who underwent their first recorded surgical fixation of an upper or lower limb fracture between 1 January 1998 and 31 December 2023.

• Limited to data between 2000 and 2025.

• All ICD-10 diagnostic codes recorded within linked hospital episodes to permit identification of fracture-related infection, comorbidity burden, complications and competing clinical diagnoses.

• All OPCS-4 procedure codes relating to orthopaedic and trauma surgery and relevant reconstructive plastic surgical procedures to enable accurate identification of index fixation procedures, subsequent revision surgery, debridement procedures, soft-tissue reconstruction, implant removal and amputation.

UoO will extract approved aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules)

Data will be extracted from the NHS England DSE to the NDORMS secure environment. The Data will be stored on servers at UoO.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

• Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA.

• Access controls granting users the minimum level of access required are in place.

• Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data.

• Multifactor authentication (MFA) is required for remote access.

• Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access.

• All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

No linkage to publicly available datasets will occur at individual record level. Aggregated findings may be presented alongside publicly available aggregate statistics (e.g. national population denominators), but no additional person-level linkage will be undertaken. There will be no requirement or attempt to identify individuals.

Outputs produced from data processing;

-Primary project report detailing national incidence, temporal trends, regional variation, and multi-state modelling results (Milestone: Months 12–15).

-Peer-reviewed manuscripts (target: 2–6 papers) covering incidence estimation, regional/provider variation, multi-state transition modelling, and risk factor analyses (first submissions Months 12–18; further papers Months 18–30).

-Conference materials and presentations for national and international meetings (e.g. BOA, OTS, infection and epidemiology conferences) across Months 12–36.

-Aggregated summary tables, figures and interactive visualisations (internal dashboards) for use by the study team and stakeholders; publicly shared visual summaries will be aggregated only and disclosure-controlled (public summaries Months 16–24).

-Plain-language summaries, infographics and patient information materials co-produced with the PPI advisory group (Months 14–18).

-Policy briefings and evidence packs for NHS England, regional commissioners and professional bodies (Months 18–24).

-Reproducible analytical code and documentation (statistical scripts, code lists) published openly where permitted (e.g. GitHub or institutional code repository) to support transparency and reproducibility (Months 18–24).

The project will produce foundational resources to be used beyond the study:

-Trial design and planning: robust national event rates and transition probabilities to power future interventional trials and prevention studies (available Months 12–24).

-Analytical resources: open sharing of code lists, analytical scripts and methodology to support reproducibility and to enable other researchers to replicate or extend analyses (Months 18–24).

-Commissioning intelligence: aggregated, regional summaries to support service planning and commissioning decisions (Months 18–24).

No person-level HES data or pseudonymised extracts will be shared or used for commercial exploitation. Should any translational or commercial opportunity arise, these will be managed under University and NHS policies and appropriate IP agreements.

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 dataset(s) from which the information was derived

Dissemination is planned and staged to reach clinical, policy and public audiences:

- Academic dissemination via high-impact peer-reviewed journals and scientific conferences (Months 12–36).

- Policy engagement through direct briefings and workshops with NHS England, regional infection networks, commissioners and professional societies (BOA, OTS, BOFAS) (Months 16–24).

- Stakeholder webinars and targeted workshops with clinical leads and commissioning groups to translate findings into service and commissioning implications (Months 16–30).

- Public and patient engagement through co-produced materials, PPI workshops and public summaries on University and project websites (Months 14–24).

- Press and media engagement if applicable coordinated with University communication teams for high-level summary findings (after peer review acceptance)

The expected measurable benefits of this project relate directly to improved patient care, more equitable service provision, and better-informed commissioning within the NHS.

In the short term (0–3 years), the study will provide reliable national estimates of the cumulative incidence and timing of fracture-related infection (FRI) requiring surgery following fracture fixation. These estimates will enable clinicians to provide evidence-based risk information during patient counselling and consent discussions. Identification of high-risk demographic and clinical groups will support more targeted surveillance and follow-up strategies, potentially reducing delays in diagnosis and treatment of infection.

At a service level, quantification of regional and provider-level variation in reoperation rates will support commissioners and clinical networks in identifying unwarranted variation and targeting quality improvement initiatives. The analysis of socioeconomic and geographic inequalities will inform proportionate service planning, contributing to more equitable musculoskeletal care across England.

In the medium term (2–4 years), the provision of robust population-level event rates and transition probabilities will directly inform the design and powering of interventional trials aimed at reducing infection risk and repeat surgery. By identifying potentially modifiable risk factors, the study will support development of enhanced peri-operative pathways and infection prevention strategies.

In the longer term (4–6 years), the anticipated benefits include a reduction in avoidable repeat surgery, reduced amputation associated with severe infection, improved long-term functional recovery and quality of life, and more efficient use of NHS resources. By establishing the national burden and determinants of FRI, this study provides a foundation for prevention-focused research and service redesign aligned with nationally identified James Lind Alliance priorities.

All benefits arise from analysis of pseudonymised national data and will be realised through improved clinical decision-making, informed commissioning, and evidence-based policy development within the NHS.

Yielded Benefits is not a requirement for new applications.