Nottingham Osteoarthritis Biomarker Study 2011
1 other identifier
observational
140
1 country
1
Brief Summary
Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers. This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 30, 2013
January 1, 2013
11 months
November 30, 2011
January 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in the levels of pro-inflammatory and anti-inflammatory lipids mediators between individuals with knee osteoarthritis and those with normal knees.
within 6 months of recruitment of last participant
Study Arms (2)
Knee osteoarthritis
No knee pain/osteoarthritis
Eligibility Criteria
\- Secondary care clinics
You may qualify if:
- All participants:
- Be able to provide written informed consent
- Aged 30 and over
- Knee OA patients:
- Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at least one compartment of the knee
- Normal controls:
- No knee pain
- No clinical or radiographic changes of knee OA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Rheumatology, University of Nottingham
Nottingham, NG5 1PB, United Kingdom
Biospecimen
Serum, urine and synovial fluid.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Doherty, MA MB FRCP
University of Nottingham
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 20, 2011
Study Start
February 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 30, 2013
Record last verified: 2013-01