An interventional study of Prosthetic joint replacement in Prosthetic Joint Infection (PJI), sponsored by Portsmouth Hospitals NHS Trust. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Portsmouth Hospitals NHS Trust · Not applicable, Interventional, and Basic science
Prosthetic joint infection (PJI) is a significant cause of failure in hip and knee arthroplasty and is often difficult to diagnose using current methods. This study aims to identify novel biomarkers for early and accurate diagnosis of PJI using nanopore sequencing technology (Oxford Nanopore Technologies). By analysing microbial profiles and host immune responses in samples from patients undergoing revision surgery, the study will compare infected and non-infected cases. Biomarkers will be investigated in periprosthetic tissue as well as less invasive sample types, including synovial fluid and blood, with the goal of improving early diagnosis and guiding future treatment strategies.
Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee arthroplasty, with an incidence of around 1-2%. Diagnosing infection can be challenging, as loosening of the implant cement (osteolysis), damage, and metal reactions can be impossible to differentiate without invasive procedures. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risks to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a predictive test for early diagnosis of infection is required. In this study, we will use nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery. This study will explore the microbes present, along with the host's immunological response, to identify potential novel biomarkers in infected samples compared to those revised for other reasons. The investigators will test for detection of these biomarkers in tissue surrounding the implant, as well as in less invasive sample types (synovial fluid and blood). These will provide novel biomarkers for diagnosis and early treatment of PJI for the future.
Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery
Procedure: Prosthetic joint replacement
Primary joint replacement
Bacterial abundance- comparison between patients
Bacterial abundance in infected biofilms compared to non-infected biofilms on hip arthroplasty prostheses.
Time frame: through study completion, an average of 1 year
Gene expression levels
Gene expression levels in patients with PJI compared to those undergoing revision surgery for other reasons (e.g. aseptic loosening (osteolysis), periprosthetic fracture, dislocation, etc.).
Time frame: through study completion, an average of 1 year
Bacterial abundance in blood and synovial samples
Secondary outcome measures are the bacterial abundance in blood and synovial samples taken from patients with infected prostheses compared to those with no infection.
Time frame: through study completion, an average of 1 year
Gene expression in blood and synovial samples
Secondary outcome measures are the bacterial gene expression in blood and synovial samples taken from patients with infected prostheses compared to those with no infection.
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Oct 2026, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Portsmouth Hospitals NHS Trust