Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
ConditionProsthetic Joint Infection (PJI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPortsmouth Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Prosthetic joint replacement
Procedure/SurgeryPrimary joint replacement
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Prosthetic joint ReplacementOther 1 intervention
Trial outcomes
Primary outcomes
1
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 year2
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 yearSecondary outcomes
1
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 year2
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Portsmouth Hospitals NHS Trust
Lead sponsor
University of Portsmouth
Collaborator
Source ClinicalTrials.gov