Prosthetic Joint Infection (PJI)DEBITNCT07838064
Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
A study testing Prosthetic joint replacement in people with Prosthetic Joint Infection (PJI), run by Portsmouth Hospitals NHS Trust at 2 sites in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection (PJI)
- What is being tested?
- Prosthetic joint replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Feb 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Erin James, 02392 286000 ext. 5153, Erin.James8@nhs.net
- Not yet recruiting
Southampton General Hospital
Southampton, SO16 6YD
Nicholas Norton, +4423 8077 7222, Nicholas.Norton@uhs.nhs.uk
About this study
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.
Read the detailed description
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.
- Conditions
- Prosthetic Joint Infection (PJI)
- Being tested
- Prosthetic joint replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic joint replacementProcedure or surgery
Primary joint replacement
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic joint Replacement | Other | Using nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery Receives: Procedure: Prosthetic joint replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial abundance- comparison between patients
Bacterial abundance in infected biofilms compared to non-infected biofilms on hip arthroplasty prostheses.
Measured: 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.).
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start13 Feb 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint Infection (PJI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
- Investigators
- Samuel Robson, Principal investigator, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838064
- Sponsor's protocol ID
- PHU/2025/17
- Acronym
- DEBIT
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
- ClinicalTrials.gov ID
- NCT07838064
- Acronym / sponsor ID
- DEBIT / PHU/2025/17
- Conditions
- Prosthetic Joint Infection (PJI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic joint Replacement | Other | Procedure: Prosthetic joint replacementUsing nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic joint replacementPrimary joint replacement | Procedure or surgery | Prosthetic joint Replacement |
Primary outcome
Bacterial abundance- comparison between patients
Time frame: through study completion, an average of 1 year
Bacterial abundance in infected biofilms compared to non-infected biofilms on hip arthroplasty prostheses.
Gene expression levels
Time frame: through study completion, an average of 1 year
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.).
2 secondary outcomes
Bacterial abundance in blood and synovial samples
Time frame: through study completion, an average of 1 year
Gene expression in blood and synovial samples
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Robson principal investigator
University of Portsmouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic joint replacement in people with Prosthetic Joint Infection (PJI), run by Portsmouth Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Robson (+442392848484, samuel.robson@port.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial abundance- comparison between patients (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.