Comparing biopsy and aspiration for diagnosing joint infections in shoulder and elbow surgeries
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
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 |
|---|---|
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wrightington, Wigan and Leigh NHS Foundation Trust Academic / other |
| Locations | 1 site (Wigan, Lancashire) |
| Trial ID | NCT06268795 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for revision shoulder or elbow arthroplasty surgery.
Not a fit: Patients who are currently on antibiotic treatment or are pregnant may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wigan, Lancashire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.