Skip to main content
OpenTrials
Completed

NCT Number: NCT05804058

Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection

Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee prostheses, with an incidence of around 1-2%. Infection can occur early (within days of surgery) or late (over a year after surgery), and no specific early markers for infection onset exist. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risk to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a more specific predictive test for early onset of infection is required.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

Over 80% of human infection is estimated to be a result of biofilm formation. Biofilms are an accumulation of microorganisms (predominantly bacteria) on a surface, resulting in a functional community which provides antibiotic resistance and a beneficial environment for the growth of pathogenic species that would otherwise be removed by the body's defences.

The use of medical implants in modern medicine has become an increasingly common occurrence, with hip and knee arthroplasty accounting for a large number of medical implant surgeries. Unfortunately, infections frequently result in failure of the implanted device (around 1-2% for knee and hip arthroplasty), requiring extensive revision surgery. Currently, no predictive biomarkers for PJI exist, and diagnostic tests require infection to have already taken hold and may often be highly invasive. Research conducted by the NIH suggests that accumulation of bacteria (known as biofilms) may account for over 80% of microbial infections in the human body and have been shown to develop on medical implants, such as those used in hip and knee arthroplasty. Bacterial biofilms on medical implants are poorly understood, making treatment very complex.

The investigators aim to identify early predictive biomarkers for PJI based on assessment of the biofilm structure on implants removed in revision surgery, either as a result of PJI or due to aseptic causes such as mechanical failure. The investigators will explore biofilm formation on hip joint prostheses using next generation sequencing (NGS) and 3D phase-contrast X-ray microscopy, and will compare bacterial diversity and biofilm structure between infected and non-infected samples to answer three main questions:

  • Can The investigators accurately describe the characteristic microbiome of hip joint prosthetic biofilms?
  • Is there a distinct characteristic microbiome or biofilm structure associated with PJI?
  • Can The investigators detect such characteristic biofilm members as biomarkers in simple blood tests?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, aged 18 years or above.
  • Due to undergo prosthetic revision surgery for any reason identified by the clinical team Willing to provide informed consent

Exclusion criteria

  • 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

Treatment and study plan

revision surgery

Procedure

Patients due to undergo prosthetic revision surgery for any reason (infection or aseptic)

Primary outcomes

  1. Characteristic Formation of bacterial biofilm on orthopaedic implants

    Time frame: 1 day study visit

    measured by infection assessment- this is the term for the measure

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • University of Portsmouth

Registry information

Official study title

Assessment of Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection

Acronym: Biofilms

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.