NCT06268795 A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
| NCT ID | NCT06268795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wrightington, Wigan and Leigh NHS Foundation Trust |
| Condition | Periprosthetic Joint Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 244 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 244 participants in total. It began in 2024-03-20 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06268795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periprosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06268795 currently recruiting?
Yes, NCT06268795 is actively recruiting participants. Contact the research team at adam.c.watts@wwl.nhs.uk for enrollment information.
Where is the NCT06268795 trial being conducted?
This trial is being conducted at Wigan, United Kingdom.
Who is sponsoring the NCT06268795 clinical trial?
NCT06268795 is sponsored by Wrightington, Wigan and Leigh NHS Foundation Trust. The trial plans to enroll 244 participants.