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

NCT02565160 | Unknown

• 1 other identifier: 15/LO/0388
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Analyse fluid from patients with swollen joints
2. 2.Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of joint swelling
3. 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.

Conditions

Osteoarthritis; Septic Arthritis; Rheumatoid Arthritis

Keywords

Osteoarthritis; Septic Arthritis

Outcome Measures

Primary Outcomes (1)

• Metabolic profiling of all three body fluids in 100 + patients

  14 months

Secondary Outcomes (1)

• DNA Profiling of 100 Joint fluid samples for the assay of the microbiome

  14 months

Study Arms (3)

Septic Arthritis

Patients suspected of having septic arthritis

Procedure: Intra-articular aspiration of Joint; Procedure: Joint irrigation washout; Procedure: Revision Joint Arthroplasty

Osteoarthritis

Patients suffering with osteoarthritis undergoing an intervention

Procedure: Intra-articular aspiration of Joint; Procedure: Joint irrigation washout; Procedure: Total Joint Arthroplasty; Procedure: Revision Joint Arthroplasty

Joint Revision

Patients who has a prosthetic joint in situ

Procedure: Intra-articular aspiration of Joint; Procedure: Revision Joint Arthroplasty

Interventions

Intra-articular aspiration of Joint PROCEDURE

Procedural sampling of the joint for diagnostic purposes

Joint Revision; Osteoarthritis; Septic Arthritis

Joint irrigation washout PROCEDURE

Procedural washout for treatment purposes

Osteoarthritis; Septic Arthritis

Total Joint Arthroplasty PROCEDURE

Osteoarthritis

Revision Joint Arthroplasty PROCEDURE

Joint Revision; Osteoarthritis; Septic Arthritis

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patients will be recruited in several scenarios.
• Anyone receiving a diagnostic aspirate of joint.
• Patients undergoing joint arthroscopy
• Patients undergoing joint replacement
• Patients undergoing prosthetic joint revision surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College NHS Trust

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine and Joint Fluid

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Infectious; Arthritis, Rheumatoid

Interventions

Arthrocentesis; Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Infections; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Chinmay Gupte, MBBChir

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)