NCT01495455

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

November 30, 2011

Last Update Submit

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

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- 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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, urine and synovial fluid.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Doherty, MA MB FRCP

    University of Nottingham

    PRINCIPAL INVESTIGATOR

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

Locations