Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study

University of Oxford1 site in 1 country150 target enrollmentJune 2010

ConditionsOsteoarthritis Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: University of Oxford
Enrollment: 150
Locations: 1
Primary Endpoint: Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This observational study seeks to identify and validate novel soluble biomarkers (within blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual with an acute knee injury, a group of individuals in which ~50% will progress to symptomatic radiographic knee osteoarthritis (OA).

150 individuals will be followed over 5 years with clinical assessment including validated questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance imaging (MRI)).

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

September 2020

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinically significant acute knee injury within 8 weeks of recruitment
•Aged 16-50
•Knee effusion, evident clinically or by MRI
•Evidence on MRI of structural injury (from list of relevant injuries)
•Informed written consent

Exclusion Criteria

•Knee injured more than 8 weeks prior to recruitment
•Pre-existing advanced radiographic OA (Kellgren Lawrence (KL) grade 3-4) of same side knee at baseline
•Known history of inflammatory/septic arthritis of same side knee
•Knee replacement - previous or planned within 2 years of study start
•Active other (treated) inflammatory disease or infection
•Positive pregnancy test
•Not consenting, or contraindication to provide blood samples:
•Bilateral mastectomy
•Bilateral fistulae for renal dialysis
•Unable to give informed written consent in English

Outcomes

Primary Outcomes

Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years

Time Frame: 2 years

Summary score for KOOS questionnaire

Secondary Outcomes

Change from baseline in Whole Organ MRI Score (WORMS) at 2 years(2 years)
Change from baseline in Kellgren Lawrence grade at 5 years(5 years)
Change from baseline in Kellgren Lawrence grade at 2 years(2 years)
Change from baseline in KOOS-4 score at 3 months(3 months)
Change from baseline in KOOS-4 score at 5 years(5 years)
Change from baseline in MRI WORMS score at 5 years(5 years)
Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years(2 years)