Multi-centre study of children with suspected bone and/or joint infection (BJI)

Plain English Summary

Background and study aims
When a child is brought to the emergency department with a painful limb without an obvious injury, the most important things for doctors to consider is:
• A serious infection of their bones or joints OR
• A temporary swelling within their joints.
Serious infections in bones are rare, but can be limb and life threatening. They require urgent treatment (antibiotics) and sometimes surgery. Temporary joint swelling however, is common and resolves without any intervention within a few days. The challenge is to quickly identify which child has an infection and which has joint swelling. Telling these apart is often not easy and involves x-rays and blood tests. Often, special tests are also used, which are ultrasound and/or MRI (Magnetic Resonance Imaging) scans. Doctors around the world are unsure about the best choice of test, particularly the ‘special tests’, and what order tests should be performed when a bone infection is suspected.
A clear pathway outlining which tests to perform and when they are needed would help to ensure that bone infections are not missed. This would also reduce unnecessary tests on children who do not have an infection.
Aims:
1. To understand how helpful special tests (i.e. ultrasound and MRI scans) are in diagnosing bone and joint infections in children.
2. To create a pathway that doctors and nurses can use in emergency departments to more successfully diagnose bone and joint infections.
Design:
The study is a multi-centre cohort study of children with suspected OM combining a retrospective cohort and a prospective validation cohort. Similar selection criteria and data collection will be employed in both cohorts.
The study will consist of two phases:
1. A multi-centre retrospective cohort study to establish the diagnostic accuracy of MRI and USS and to develop a clinical algorithm for diagnosis;
2. A multi-centre prospective cohort study to externally validate the clinical algorithm.
3. In parallel, a qualitative study will inform the management of patients being investigated for OM, including how best to address their information needs and how to support them during the process.

Who can participate?
Prospective and Retrospective Studies:
Children and young people under 16 years old with a diagnosis of bone/joint infection (BJI) suspected by the treating clinician.
Qualitative Information Study:
Patients and families with a proven BJI and a sub-set of patients and families who have undergone investigations for suspected BJI but received other diagnoses. Also, health professionals involved with the care of children with a suspected BJI.

What does the study involve?
It is an observational study and does not involve any extra test or visits to the hospital. The research team will collect the results of all investigations children with suspected infection undergo during initial presentation and at three months (i.e. what assessments they have received, the results of these assessments and the diagnosis the child was given).
With their consent, we will contact the parents/carers of the participants at 3 months from initial presentation. This will involve a short phone call/email to find out how the child is doing and whether they received treatment anywhere else. If the child received treatment elsewhere, the research team will inform the original recruiting site and request they seek further information from the relevant non-participating hospital/GP.
The parents/carers and the child may also be invited to take part in our sub study (the qualitative information study discussed above) exploring the experiences of the clinical investigations the child receives.

What are the possible benefits and risks of participating?
There is no direct benefit from taking part in this study. However, participation will help improve the way children with a painful limb are investigated, which may lead to better care and outcomes for children in the same situation in the future. There is no risk arising from participation in the study as it is only an observational study. Participation in the study will not influence clinical decisions and treatment pathways.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
April 2022 to September 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
tim.theologis@msd.ox.ac.uk
picbone@ndorms.ox.ac.uk

Study website

Contact information

Mr Tim Theologis
Scientific, Principal Investigator

Surgical Intervention Trials Unit, Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7HE
United Kingdom

ORCID ID	0000-0002-4758-9081
Phone	+44 (0) 1865 223491
Email	tim.theologis@msd.ox.ac.uk

Dr Anjali Shah
Public

Surgical Intervention Trials Unit, Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7HE
United Kingdom

Phone	+44 (0) 1865 223491
Email	picbone@ndorms.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Oxford
University/education

Research Governance, Ethics & Assurance
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom

Phone	+44 (0)1865 616480
Email	rgea.sponsor@admin.ox.ac.uk
Website	https://researchsupport.admin.ox.ac.uk/contacts/rgea
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

43404 PICBONE Protocol_V1.0_21Dec2022.pdf

ISRCTN15471635 PICBONE_Protocol_V2.0_06Feb2024.pdf

ISRCTN15471635_Protocol_V3.0_31Oct2024.pdf

Editorial Notes

19/03/2025: A protocol v3.0 (not peer-reviewed) was uploaded as an additional file.
27/12/2024: The study participating centres were updated to remove NHS Lothian and East Suffolk and North Essex NHS Foundation Trust and add Ipswich Hospital.
12/07/2024: The following changes were made to the trial record:
1. The public contact was changed.
2. The overall end date was changed from 30/09/2024 to 30/09/2025.
3. The study website was added.
4. Link to participant information sheet added.
5. The inclusion criteria were changed.
6. The exclusion criteria were changed.
7. The recruitment start date was changed from 01/04/2023 to 16/06/2023.
8. The recruitment end date was changed from 30/09/2024 to 31/12/2024.
9. The study participating centres Imperial College Healthcare NHS Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Kings College Hospital NHS Foundation Trust, NIHR CLAHRC North Thames, Somerset NHS Foundation Trust were removed and Airedale NHS Trust, Hull University Teaching Hospitals NHS Trust, The Hillingdon Hospitals NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust, Royal Cornwall Hospitals NHS Trust, East Suffolk and North Essex NHS Foundation Trust, Kettering General Hospital NHS Foundation Trust, Maidstone and Tunbridge Wells NHS Trust, Manchester University NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust, Nottingham University Hospitals NHS Trust - City Campus, North West Anglia NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Barts Health NHS Trust were added.
10. Uploaded protocol v2.0 (not peer-reviewed) as an additional file.
05/06/2023: Internal review.
03/04/2023: Trial's existence confirmed by Solihull Research Ethics Committee