Status:
RECRUITING
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Lead Sponsor:
Wrightington, Wigan and Leigh NHS Foundation Trust
Conditions:
Periprosthetic Joint Infection
Eligibility:
All Genders
18+ years
Brief 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 peri...
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 revision...
Eligibility 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.
Key Trial Info
Start Date :
March 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06268795
Start Date
March 20 2024
End Date
September 1 2028
Last Update
July 28 2025
Active Locations (1)
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1
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, Lancashire, United Kingdom, WN6 9EP