A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 244

Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust

Location: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust Wigan Lancashire

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06268795). StuddyBuddy aggregates publicly available trial information.