About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Comparison of diagnostic accuracy
Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples
Secondary outcomes
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.
Sponsors and contacts
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