Analysis of Human Knee Joint Fluid Using Metabonomic, Genomic and Tribology Techniques
NCT ID: NCT02565160
Last Updated: 2019-08-20
Study Results
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Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2015-10-31
2021-10-31
Brief Summary
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The investigators aim to use well established metabonomic techniques to:
1. Analyse fluid from patients with swollen joints
2. Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of joint swelling
3. 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.
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Detailed Description
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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:
1. Each pathology will have a unique metabolic profile
2. Inflammatory osteoarthritis will contain a different metabolic profile and potentially biomarkers to treatment and/or response
3. Specifically the presence and detection of organism sub-type and biofilm biomarkers
4. These profiles can be characterised by analysis of blood, urine and joint fluid
5. This data can be used to generate diagnostic tests that will aid management of a swollen joint.
6. There will be a correlation between metabolic profile and lubricant properties of the joint fluid, that can be utilised in future engineering strategies to manage osteoarthritis.
1\. To analyse joint fluid from osteoarthritic joints to identify potential biomarkers of the disease and further understanding of the cartilage destruction pathways 2. To assess population variances in joint fluid composition using metabonomics and whether this composition correlates to arthropathy of joints 3. To study the lubrication and wear properties of the joint fluid and understand how the metabolic profile influences lubrication and subsequently joint wear.
4\. To study joint fluid using metabonomics to identify biomarkers of bacterial colonisation in tandem with microbial 16S Polymerase Chain Reaction and genomic sequencing.
Project Timeline:
Phases of the project are to be as follows:
Full research, Site and Ethical Approval: Provisional ethics is already granted. No obstacles to research and site approval are expected and this should be achieved shortly afterwards. (success = ethical approval) Expected June 2015
Sample Collection: The investigators aim to recruit 150 patients to the study capturing a conservative estimate of 10 per week. All orthopaedic patients will be targeted. The majority are expected to be recruited from the elective theatres. (success = 150 pts recruited) June - September 2015 (onwards)
Metabonomic Analysis Method Development: Establishing Nuclear Magnetic Resonance (NMR) methodology for metabolic profiling of synovial fluid as a sample matrix. Method development of Liquid Chromatography Mass Spectroscopy (LCMS) untargeted and targeted methodology for synovial fluid (success = achieving robust, sensitive methodology) October 2015
Joint Fluid Tribology: Analysis of the lubricating properties of the joint fluid (success = 150 samples assayed) October - December 2015
Metabonomic Analysis: In order to yield the maximum results the investigators aim to analyse using NMR screening with untargeted and targeted LCMS analysis. With approximately 150 patients and thus 450 body fluid samples the investigators are estimating an analysis time of 6 months (success = metabolic profiling and targeted analysis) November - April 2016
Microbial Genetic Analysis: PCR and sequencing of the microbial genetic content of the joint fluid (success = completion in 150 samples) April - June 2016
Collation of results, Analysis and Reporting: Preparation of results for submission to a journal with an impact factor \>10. (success = editorial acceptance of manuscript) July - October 2016
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Septic Arthritis
Patients suspected of having septic arthritis
Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes
Joint irrigation washout
Procedural washout for treatment purposes
Revision Joint Arthroplasty
Osteoarthritis
Patients suffering with osteoarthritis undergoing an intervention
Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes
Joint irrigation washout
Procedural washout for treatment purposes
Total Joint Arthroplasty
Revision Joint Arthroplasty
Joint Revision
Patients who has a prosthetic joint in situ
Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes
Revision Joint Arthroplasty
Interventions
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Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes
Joint irrigation washout
Procedural washout for treatment purposes
Total Joint Arthroplasty
Revision Joint Arthroplasty
Eligibility Criteria
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Inclusion Criteria
1. Anyone receiving a diagnostic aspirate of joint.
2. Patients undergoing joint arthroscopy
3. Patients undergoing joint replacement
4. Patients undergoing prosthetic joint revision surgery
Exclusion Criteria
* Any female patient who is pregnant will be excluded.
* Any patient medicated with anti-coagulants will be excluded.
16 Years
90 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Chinmay Gupte, MBBChir
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College NHS Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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15/LO/0388
Identifier Type: -
Identifier Source: org_study_id
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