HIstology and Microbiome to Diagnose and Evaluate Outcome in BJI
Research type
Research Study
Full title
Investigating the Influence of Histopathology and Microbiome in Complex Bone and Joint Infection (BJI) on Diagnosis and Patient Experienced Outcome
IRAS ID
297214
Contact name
Cher Bing Chuo
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
22/23 01, Hull York Medical School Ethics Committee Approval
Duration of Study in the UK
3 years, 1 months, 14 days
Research summary
Complex bone and joint infections (BJI) are typically managed in a multidisciplinary team setting. These include where no orthopaedic metalware is present and where orthopaedic metalware is present. The recognised gold standard for diagnosis of BJI is positive microbiological isolation of the same micro-organisms from ≥2 deep tissue and/or synovial fluid samples. However, the ability to successfully identify the presence of micro-organisms from culture in artificial joint infections (PJI) is poor (5%-42%) and the ability of routine cultures to identifying the infecting micro-organisms is low (39%-70%). Because of antibiotic administraion, responsible micro-organisms being slow and difficult to culture and the biofilm effect. It is important to identify if bone or prosthetic joints are infected in such scenarios, as treatment failures due to undertreatment or non-targeted treatment may result in persistent skin sinuses or pustular discharge, further surgical intervention for infection including amputation, and infection-related mortality. On the other hand, indiscriminate use of antibiotics or overtreatment may lead to the development of antibiotic-resistant micro-organisms. \nThe evidence supporting the internationally-accepted definition of PJI (2021) by the European Bone and Joint Infection Society and for fracture-related infection (FRI) is limited, particularly the features of tissue histopathology (confirmatory criteria for PJI/FRI). Furthermore, molecular techniques have been used to study the composition of the human microbiome in a wide variety of clinical settings, but have not yet been applied as a standard clinical diagnostic tool for bone and joint infections. No other study has investigated the employment of third/fourth generation molecular techniques as a diagnostic tool for complex bone and joint infections. This exploratory study will explore the feasibility of this potential application, and characterise these results in relation to microbiology findings, patient experienced outcomes and internationally agreed definitions. It will also better characterise and define the histolopathological parameters as a confirmatory criteria for PJI/FRI.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0152
Date of REC Opinion
24 Nov 2022
REC opinion
Further Information Favourable Opinion