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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust

    Wigan, Lancashire, WN6 9EP

    Zaid Z Hamoodi, zaid.hamoodi@nhs.net

    Recruiting

Other trials in United Kingdom

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted20 Feb 2024
  2. Study start20 Mar 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

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)
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

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.

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