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Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)

RecruitingNAAges 18 Years - anyAllPortsmouth Hospitals NHS Trust
NCT07838064 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or Female, aged 18 years or above. * Due to undergo prosthetic revision surgery for any reason identified by the clinical team. * Participant is willing and able to give informed consent for participation in the study. * Pre-operative blood samples and at least 5 substantial peri-prosthetic tissue samples of a suitable size to be distributed between labs as outlined were successfully collected (note that it may not be possible to collect synovial fluid in all cases). Exclusion Criteria: * The participant has previously undergone any kind of revision surgery for their hip implant. * The participant has received any antibiotic treatment within the previous two weeks (excluding antibiotics at induction). * Participant lacking capacity to give informed consent. * Any other clinical reason the participant should not be included in the study- at the discretion of the clinical team.
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What it tests

  • Prosthetic joint replacement
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Where

2 sites
Queen Alexandra Hospital
Portsmouth, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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