ELIJA v1.0
Research type
Research Study
Full title
Evaluation of Synvichor in patients with undifferentiated joint pain to discriminate between infectious and non-infectious joint inflammation
IRAS ID
329343
Contact name
Iain McNamara
Contact email
Sponsor organisation
OrthoDx
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Joint infections are a musculoskeletal emergency. Infection within a joint can have catastrophic consequences if not diagnosed and treated urgently. A failure of urgent diagnosis and treatment can lead to joint destruction within 24 hours and permanent disability because of this. Early and accurate diagnosis is important to start appropriate treatment to prevent irrevocable joint damage.
Current tests are poor at diagnosing joint infection, often over- or under-diagnosing. The gold standard for confirming joint infection is growth of bacteria, or bacterial products, from the joint fluid; however, evidence suggests this may not happen in over two thirds of cases. The diagnosis then relies mainly on clinical judgement based on clinical observations, imaging, and a series of blood tests.
The Orthodx assay, SynvIchor, is a new test that measures host white cell gene expression in the fluid taken from the joint cavity (synovial fluid). This test has been shown to be very useful in differentiating between infectious and non-infectious joint pain in adults.
This study will investigate the performance of the OrthoDx test in patients presenting with undifferentiated joint pain. The test will be done on the same samples of synovial fluid that is routinely collected from a joint cavity during a standard infection profile workup. The OrthoDx test results will be compared with current tests used to diagnose joint infections in patients. Data from the participants routine baseline and 6 week appointment (where available) will be collected to confirm their routine clinical diagnosis.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
24/PR/1137
Date of REC Opinion
16 Oct 2024
REC opinion
Further Information Favourable Opinion