Periprosthetic Joint Infection Test Bundle Assessment
Research type
Research Study
Full title
Assessment of the use of a novel test bundle in a high volume revision arthroplasty unit
IRAS ID
291851
Contact name
Martin Sarungi
Contact email
Sponsor organisation
Golden Jubilee Foundation
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Periprosthetic joint infection (PJI) is a challenging cause of joint replacement (arthroplasty) failure since the beginning of modern joint replacements. While early or late acute infections often presents with dramatic and “classical” signs of general infection symptoms, such as pain, redness, increased temperature, loss of function with or without discharging wounds and sinuses, there is a real challenge in diagnosing the “low virulence” or so called “low grade” infections which have very minimal or no obvious clinical signs. Misdiagnosed infection may lead to mistreatment, which can then cause limb or life threatening conditions.\n\nOne of the steps in diagnosing “low grade” infection is a procedure called aspiration on the painful joint (knee/hip) where fluid is taken from the joint space. This “synovial“ fluid is then sent for analysis to investigate for infectious organisms. Currently there is no single synovial fluid test which produce 100% specificity and sensitivity, therefore a “bundle of tests” are recommended by different infection societies. \n\nThe study proposes is to assess the reliability and usefulness of a novel “infection test bundle” comparing it to our current standard practice. All patients with suspected infection or unexplained pain after joint replacement have synovial tests for microbial culture and sensitivity as standard. Some patients with suspected periprosthetic joint infection already have their fluid analysed using the novel “infection test bundle” based on clinical indication and discussion with our microbiologist. In this study, patients are asked to give their consent for the research team to analyse the results of the “novel infection test” bundle and compare those results with the analysis of standard synovial fluid tests and microbiology samples taken during revision surgery or as a part of standard investigation of painful joint replacement. Patients who do not consent for their synovial fluid results to be analysed and compared to the standard microbiology samples or joint aspirates will still be eligible for the novel infection test bundle if clinically indicated and discussed with microbiologist, but their result will not be used for this study. For this study, the only difference for consented patients will be the comparison between the different analyses performed. \n\nThe study does not involve taking any additional synovial fluid (the same amount of fluid would be taken during aspiration).\n\nThe Scottish Health Technology Group recommended further studies of this novel infection test bundle.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0092
Date of REC Opinion
29 Jun 2021
REC opinion
Favourable Opinion