Periprosthetic Joint InfectionNCT06268795
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
An observational study of Periprosthetic Joint Infection, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection
- How many people
- 244 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2024to 1 Sep 2028
- Phase
- Observational
- 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
Study population: All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.
Who may be able to join
- Aged: 18 years or older.
- A participant is willing and able to give informed consent for participation in the study.
- Patient undergoing revision shoulder or elbow arthroplasty surgery.
- Previous anatomic total shoulder arthroplasty (TSA), shoulder hemiarthroplasty (HA), reverse total shoulder arthroplasty (RTSA), total elbow arthroplasty (TEA), distal humeral hemiarthroplasty (DHH) and radial head arthroplasty (RHA).
Who cannot join
- Refusal of consent.
- Antibiotic treatment was not stopped 2 weeks before aspiration or biopsy.
- Pregnancy.
- Part of any other trial with similar interventions unless previously agreed on with investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, Lancashire, WN6 9EP
Zaid Z Hamoodi, zaid.hamoodi@nhs.net
About this study
The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI.
Read the detailed description
A PJI is a severe complication of arthroplasty surgery and one of the leading causes of revising joint replacements. It accounts for 19% of shoulder arthroplasty and 28% of elbow arthroplasty revisions. The successful management of patients with PJI depends on an early and accurate diagnosis, however, this can be challenging. To optimise the diagnosis of PJI, a combination of clinical findings, laboratory results from peripheral blood and synovial fluid (WBC and CRP), microbiological data, histological evaluation of periprosthetic tissue, intraoperative inspection, and radiographic results are considered.
Percutaneous joint aspiration makes an integral part of each of the diagnostic criteria for PJI (EBJIS, MSIS, ICM, and IDSA) and the current shoulder and elbow PJI guidelines from the British Elbow and Shoulder Society (BESS) state that a joint aspiration should be attempted in all patients. Aspiration allows for the identification of bacteria, the determination of antibiotic resistance and sensitivity patterns to guide anti-microbial management before surgery at relatively low costs, however, aspiration has a large variance in its diagnostic value. Studies have been performed to assess the diagnostic accuracy of percutaneous joint aspiration of suspected PJI in hip and knee arthroplasty but there is currently no evidence of utility in the diagnosis of PJI in shoulder and elbow arthroplasty.
The organisms causing PJI in shoulder and elbow arthroplasty may be different from lower limb arthroplasty and this may impact the accuracy of investigation findings. Cutibacterium (Propionibacterium) acnes is commonly isolated following upper limb surgery and is skin commensal. Therefore, distinguishing its presence as a pathogen can prove challenging due to its low virulence, limited local inflammatory response, biofilm formation, difficulty in culturing the bacteria and rising resistance rate to anti-microbial agents. This makes it even more essential that diagnostic tests can accurately identify causative PJI pathogens.
The gold standard for the diagnosis of PJI is open biopsy. This is usually performed by obtaining tissue samples intraoperatively. Radiologically guided biopsy is also recommended to be performed in certain cases e.g. not clinically confirmed PJI and surgery not feasible. To improve the diagnostic accuracy in suspected PJI of the shoulder and elbow, it has been hypothesised that pre-revision tissue biopsies, much like that for hip and knee arthroplasties, for microbiological and histological analyses are of superior diagnostic value than percutaneous aspiration.
- Conditions
- Periprosthetic Joint Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of diagnostic accuracy
Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples
Measured: 36 months
Secondary outcomes (1)
Culture analysis
To determine the sensitivity, specificity, positive/negative predictive value, negative, diagnostic accuracy \& positive/negative likelihood ratios of needle aspiration and open biopsy for the diagnosis of periprosthetic joint infection in shoulder and elbow replacement.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268795
- Sponsor's protocol ID
- BASE
- Status last verified
- Jul 2025
- First submitted
- 12 Feb 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
- ClinicalTrials.gov ID
- NCT06268795
- Acronym / sponsor ID
- BASE
- Conditions
- Periprosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Feb 2024 (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.
The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI.
Detailed description
A PJI is a severe complication of arthroplasty surgery and one of the leading causes of revising joint replacements. It accounts for 19% of shoulder arthroplasty and 28% of elbow arthroplasty revisions. The successful management of patients with PJI depends on an early and accurate diagnosis, however, this can be challenging. To optimise the diagnosis of PJI, a combination of clinical findings, laboratory results from peripheral blood and synovial fluid (WBC and CRP), microbiological data, histological evaluation of periprosthetic tissue, intraoperative inspection, and radiographic results are considered.
Percutaneous joint aspiration makes an integral part of each of the diagnostic criteria for PJI (EBJIS, MSIS, ICM, and IDSA) and the current shoulder and elbow PJI guidelines from the British Elbow and Shoulder Society (BESS) state that a joint aspiration should be attempted in all patients. Aspiration allows for the identification of bacteria, the determination of antibiotic resistance and sensitivity patterns to guide anti-microbial management before surgery at relatively low costs, however, aspiration has a large variance in its diagnostic value. Studies have been performed to assess the diagnostic accuracy of percutaneous joint aspiration of suspected PJI in hip and knee arthroplasty but there is currently no evidence of utility in the diagnosis of PJI in shoulder and elbow arthroplasty.
The organisms causing PJI in shoulder and elbow arthroplasty may be different from lower limb arthroplasty and this may impact the accuracy of investigation findings. Cutibacterium (Propionibacterium) acnes is commonly isolated following upper limb surgery and is skin commensal. Therefore, distinguishing its presence as a pathogen can prove challenging due to its low virulence, limited local inflammatory response, biofilm formation, difficulty in culturing the bacteria and rising resistance rate to anti-microbial agents. This makes it even more essential that diagnostic tests can accurately identify causative PJI pathogens.
The gold standard for the diagnosis of PJI is open biopsy. This is usually performed by obtaining tissue samples intraoperatively. Radiologically guided biopsy is also recommended to be performed in certain cases e.g. not clinically confirmed PJI and surgery not feasible. To improve the diagnostic accuracy in suspected PJI of the shoulder and elbow, it has been hypothesised that pre-revision tissue biopsies, much like that for hip and knee arthroplasties, for microbiological and histological analyses are of superior diagnostic value than percutaneous aspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.
Key inclusion criteria (4 listed)
- Aged: 18 years or older.
- A participant is willing and able to give informed consent for participation in the study.
- Patient undergoing revision shoulder or elbow arthroplasty surgery.
- Previous anatomic total shoulder arthroplasty (TSA), shoulder hemiarthroplasty (HA), reverse total shoulder arthroplasty (RTSA), total elbow arthroplasty (TEA), distal humeral hemiarthroplasty (DHH) and radial head arthroplasty (RHA).
Key exclusion criteria (4 listed)
- Refusal of consent.
- Antibiotic treatment was not stopped 2 weeks before aspiration or biopsy.
- Pregnancy.
- Part of any other trial with similar interventions unless previously agreed on with investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of diagnostic accuracy
Time frame: 36 months
Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples
1 secondary outcome
Culture analysis
Time frame: 14 days
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 28 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Joint Infection, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Adam Watts (01257 256259, adam.c.watts@wwl.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of diagnostic accuracy (time frame: 36 months). 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 28 Jul 2025.