BASE study
Research type
Research Study
Full title
A diagnostic test accuracy study comparing Biopsy to Aspiration in Shoulder and Elbow replacement revision surgery
IRAS ID
305673
Contact name
Adam Watts
Contact email
Sponsor organisation
Wrightington Wigan and Leigh NHS Foundation Trust
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
A deep joint infection is a severe complication of joint replacement surgery and can mean further surgery for patients. The successful management of patients with deep joint infection depends on an early and accurate diagnosis. This however can be challenging. The diagnosis is made through a combination of clinical examination findings, laboratory results, intraoperative inspection, and radiographic results. Studies have been performed to assess the accuracy of joint aspiration in suspected deep joint infections in the hip and knee by passing a needle through the skin into the joint, but there are currently no similar studies in shoulder and elbow replacement surgery.
The focus of this study is to compare the accuracy of a needle aspiration against taking a sample of tissue from the joint at the time of revision surgery (open tissue biopsy) for the detection of shoulder and elbow deep joint infection. This would be the first study of its kind in shoulder and elbow replacement surgery.
We need a total 318 patients to enter the study. Patients are identified by the operating surgeons and specialist nurses through outpatient clinics when listed for revision of shoulder or elbow replacement surgery at Wrightington hospital. Identified patients will only be included in the study after giving informed consent. Patients will receive the routine care before and after surgery. The only extra step includes performing a needle aspiration in the operating theatre after the patient is anaesthetised (so the patient will not feel the needle aspiration). The surgery will then be performed as per the standard clinical practice. This will not change the care for the patient. Patients will not have any extra costs from taking part in the study.
This study can potentially establish the accuracy of aspiration against the gold standard of intra-operative tissue samples. The results of this study have the potential to change practice.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
23/NW/0385
Date of REC Opinion
2 Jan 2024
REC opinion
Favourable Opinion