Clinical Trial: Analysis of Human Knee Joint Fluid Using Metabonomic, Genomic and Tribology Techniques
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Looking for Biomarkers in Human Joint Fluid Using Metabonomic, Microbiomic and Tribological Analysis
Brief Summary:
Making the diagnosis underlying a painful, swollen joint currently involves aspiration followed by numerous microbiological and biochemical laboratory tests. This can be costly, time consuming and in the case of an acutely swollen joint, lead to a lengthy inpatient admission. There is an unmet need to provide a quick, easy, reliable dipstick like test to analyse joint fluid in the community, clinic, or emergency department setting.
The investigators aim to use well established metabonomic techniques to:
- Analyse fluid from patients with swollen joints
- Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of joint swelling
- Correlate this with lubrication and wear properties of the fluid The long term goal is to develop time saving, cost effective, non-invasive diagnostic tests to improve management of a swollen joint. The biomedical research centre at Imperial provides a unique and unparalleled clinical and scientific environment to conduct this research. The Imperial College division of Computational and Systems Medicine has an international reputation in metabonomics and this, together with the high volume of patients with swollen joints treated at Imperial National Health Service Trust (c1000/yr) ensures that the study can take place in an environment conductive to success.
Detailed Summary:
Swollen joints represent a diagnostic challenge. Possible diagnoses include: osteoarthritis, gout, rheumatological disease or infection. Diagnostic methods are limited to microscopy, microbiology and trace analysis. These methods can be slow, time consuming, expensive and often inconclusive.
Osteoarthritis varies in the severity of any inflammatory response and subsequent symptoms. To date no molecular link has been established to explain this ambiguity. Previous studies have identified metabolites of the inflammatory response but failed to investigate any correlation with symptoms or response to targeted injections.
Microbial infections of joints are destructive. It typically takes 2-3 days to identify a causative organism and confirm diagnosis. Recent studies suggest low-level bacterial colonisation within joints. The investigators aim to analyse the joint fluid for any bacterial colonisation using enrichment and 16S Polymerase Chain Reaction (PCR) then correlate the results to the metabolic profile. In addition the investigators aim to seek metabolites indicative of the presence of a biofilm which, if present severely limits treatment options.
Metabonomics is the quantitative measurement of the dynamic multiparametric response of a living system to pathophysiological stimuli or genetic modification. This provides a global metabolic profile despite a complex biological sample and has proven useful in many fields.
Our hypotheses are:
- Each pathology will have a unique metabolic profile
- Inflammatory osteoarthritis will contain a different metabolic profile and potentially biomarkers to treatment and/or response
Sponsor: Imperial College London
Current Primary Outcome: Metabolic profiling of all three body fluids in 100 + patients [ Time Frame: 14 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: DNA Profiling of 100 Joint fluid samples for the assay of the microbiome [ Time Frame: 14 months ]
Original Secondary Outcome: Same as current
Information By: Imperial College London
Dates:
Date Received: May 28, 2015
Date Started: October 2015
Date Completion:
Last Updated: August 26, 2016
Last Verified: August 2016
