Comparing biopsy and aspiration for diagnosing joint infections in shoulder and elbow surgeries
Official title: A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Run by Wrightington, Wigan and Leigh NHS Foundation Trust · NCT06268795 · Data updated 2026-11-12
This study is testing whether using a needle to take fluid from the joint or doing a surgical biopsy is better for diagnosing infections in patients having shoulder or elbow surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 244 (estimated) |
| Sponsor | Wrightington, Wigan and Leigh NHS Foundation Trust Academic / other |
| Locations | 1 site (Wigan, Lancashire) |
| Status | Recruiting |
| Started | March 20, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06268795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are scheduled for revision shoulder or elbow arthroplasty surgery.
✕Probably not a fit
Patients who are currently on antibiotic treatment or are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the diagnostic accuracy of percutaneous aspiration versus open biopsy for detecting periprosthetic joint infection (PJI) in patients undergoing revision shoulder and elbow arthroplasty. It will utilize microbiological and histological methods to assess the effectiveness of joint aspiration as a pre-operative diagnostic tool. Given the challenges in diagnosing PJI, the study seeks to optimize the diagnostic pathway by integrating clinical findings, laboratory results, and imaging data. The findings could potentially inform better management strategies for patients facing this severe complication.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of joint infections, improving treatment outcomes for patients.
How similar studies have gone: While studies have shown success in assessing diagnostic accuracy for hip and knee arthroplasties, this approach for shoulder and elbow arthroplasties is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: * 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.
Where it's running
-
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, Lancashire, United Kingdom Recruiting
Study contacts
- Study coordinator: Adam Watts
- Email: adam.c.watts@wwl.nhs.uk
- Phone: 01257 256259
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.