Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06268795 |
| Other study ID # |
BASE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2024 |
| Est. completion date |
September 1, 2028 |
Study information
| Verified date |
April 2024 |
| Source |
Wrightington, Wigan and Leigh NHS Foundation Trust |
| Contact |
Adam Watts |
| Phone |
01257 256259 |
| Email |
adam.c.watts[@]wwl.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
A PJI is a severe complication of arthroplasty surgery and one of the leading causes of
revising joint replacements. It accounts for 19% of shoulder arthroplasty and 28% of elbow
arthroplasty revisions. The successful management of patients with PJI depends on an early
and accurate diagnosis, however, this can be challenging. To optimise the diagnosis of PJI, a
combination of clinical findings, laboratory results from peripheral blood and synovial fluid
(WBC and CRP), microbiological data, histological evaluation of periprosthetic tissue,
intraoperative inspection, and radiographic results are considered.
Percutaneous joint aspiration makes an integral part of each of the diagnostic criteria for
PJI (EBJIS, MSIS, ICM, and IDSA) and the current shoulder and elbow PJI guidelines from the
British Elbow and Shoulder Society (BESS) state that a joint aspiration should be attempted
in all patients. Aspiration allows for the identification of bacteria, the determination of
antibiotic resistance and sensitivity patterns to guide anti-microbial management before
surgery at relatively low costs, however, aspiration has a large variance in its diagnostic
value. Studies have been performed to assess the diagnostic accuracy of percutaneous joint
aspiration of suspected PJI in hip and knee arthroplasty but there is currently no evidence
of utility in the diagnosis of PJI in shoulder and elbow arthroplasty.
The organisms causing PJI in shoulder and elbow arthroplasty may be different from lower limb
arthroplasty and this may impact the accuracy of investigation findings. Cutibacterium
(Propionibacterium) acnes is commonly isolated following upper limb surgery and is skin
commensal. Therefore, distinguishing its presence as a pathogen can prove challenging due to
its low virulence, limited local inflammatory response, biofilm formation, difficulty in
culturing the bacteria and rising resistance rate to anti-microbial agents. This makes it
even more essential that diagnostic tests can accurately identify causative PJI pathogens.
The gold standard for the diagnosis of PJI is open biopsy. This is usually performed by
obtaining tissue samples intraoperatively. Radiologically guided biopsy is also recommended
to be performed in certain cases e.g. not clinically confirmed PJI and surgery not feasible.
To improve the diagnostic accuracy in suspected PJI of the shoulder and elbow, it has been
hypothesised that pre-revision tissue biopsies, much like that for hip and knee
arthroplasties, for microbiological and histological analyses are of superior diagnostic
value than percutaneous aspiration.
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