RecruitingNCT06268795
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Sponsor
Wrightington, Wigan and Leigh NHS Foundation Trust
Enrollment
244 participants
Start Date
Mar 20, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06268795
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