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RecruitingNCT06268795Updated Jul 28, 2025

A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)

An observational study in Periprosthetic Joint Infection, sponsored by Wrightington, Wigan and Leigh NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Wrightington, Wigan and Leigh NHS Foundation Trust · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
244
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Periprosthetic Joint Infection
03

In context

Lead sponsor

Wrightington, Wigan and Leigh NHS Foundation Trust is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
244 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Comparison of diagnostic accuracy

    Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples

    Time frame: 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.

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
  • Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
    Wigan, Lancashire WN6 9EP, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06268795
Lead sponsor
Wrightington, Wigan and Leigh NHS Foundation Trust
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Mar 20, 2024
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jul 28, 2025

Study contacts

Adam Watts
Contact
adam.c.watts@wwl.nhs.uk
01257 256259
Zaid Hamoodi
Contact
zaid.hamoodi@nhs.net
07533704775

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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