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Analysis of Human Knee Joint Fluid Using Metabonomic, Genomic and Tribology Techniques

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ClinicalTrials.gov Identifier: NCT02565160
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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:

  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.

Condition or disease Intervention/treatment
Osteoarthritis Septic Arthritis Rheumatoid Arthritis Procedure: Intra-articular aspiration of Joint Procedure: Joint irrigation washout Procedure: Total Joint Arthroplasty Procedure: Revision Joint Arthroplasty

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Looking for Biomarkers in Human Joint Fluid Using Metabonomic, Microbiomic and Tribological Analysis
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Group/Cohort Intervention/treatment
Septic Arthritis
Patients suspected of having septic arthritis
Procedure: Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes

Procedure: Joint irrigation washout
Procedural washout for treatment purposes

Procedure: Revision Joint Arthroplasty
Osteoarthritis
Patients suffering with osteoarthritis undergoing an intervention
Procedure: Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes

Procedure: Joint irrigation washout
Procedural washout for treatment purposes

Procedure: Total Joint Arthroplasty
Procedure: Revision Joint Arthroplasty
Joint Revision
Patients who has a prosthetic joint in situ
Procedure: Intra-articular aspiration of Joint
Procedural sampling of the joint for diagnostic purposes

Procedure: Revision Joint Arthroplasty



Primary Outcome Measures :
  1. Metabolic profiling of all three body fluids in 100 + patients [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. DNA Profiling of 100 Joint fluid samples for the assay of the microbiome [ Time Frame: 14 months ]

Biospecimen Retention:   Samples With DNA
Blood, Urine and Joint Fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In summary we expect to recruit 150 subjects and sample three body fluid types. In some cases control and multiple time points will be collected.
Criteria

Inclusion Criteria:

  • The patients will be recruited in several scenarios.

    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:

  • No patient under 16 years or age or older than 80 years will be entered for the study.
  • Any female patient who is pregnant will be excluded.
  • Any patient medicated with anti-coagulants will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565160


Locations
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United Kingdom
Imperial College NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Chinmay Gupte, MBBChir Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Study Protocol  [PDF] January 8, 2015


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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02565160     History of Changes
Other Study ID Numbers: 15/LO/0388
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Osteoarthritis
Septic Arthritis
Additional relevant MeSH terms:
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Arthritis, Infectious
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Infection