Actively Recruiting
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Led by Wrightington, Wigan and Leigh NHS Foundation Trust · Updated on 2025-07-28
244
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to compare how well two diagnostic methods—percutaneous aspiration and open biopsy—detect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection (PJI) is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.
CONDITIONS
Brief Title
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Willing and able to give informed consent
- Undergoing revision surgery for shoulder or elbow arthroplasty
- Have had anatomic total shoulder arthroplasty, shoulder hemiarthroplasty, reverse total shoulder arthroplasty, total elbow arthroplasty, distal humeral hemiarthroplasty, or radial head arthroplasty
You will not qualify if you...
- Refusal to give consent
- Antibiotic treatment not stopped at least 2 weeks before aspiration or biopsy
- Pregnancy
- Participation in another trial with similar interventions unless agreed with investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days
Participants undergo diagnostic procedures including percutaneous joint aspiration and tissue biopsy to identify infection in shoulder or elbow arthroplasty revision surgery.
1 to 2 visits depending on diagnostic procedures
Duration - Up to 36 months
Participants are monitored for diagnostic accuracy and clinical outcomes related to infection over time.
Trial Site Locations
Total: 1 location
1
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, Lancashire, United Kingdom, WN6 9EP
Actively Recruiting
Research Team
A
Adam Watts
Z
Zaid Hamoodi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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