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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWrightington, Wigan and Leigh NHS Foundation Trust

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed