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

This trial does not accept healthy volunteers

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 population

All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Comparison of diagnostic accuracy

Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples

Time frame
36 months

Secondary outcomes

1

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.

Time frame
14 days

Other outcomes

Sponsors and contacts

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