Predicting Osteoarthritis Risk Following Knee Injury.

Osteoarthritis Clinical Trial

— KICK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02667756
• Other study ID #: cro1532
• Secondary ID: 10/H0805/39
• Status: Active, not recruiting
• Start date: June 2010
• Est. completion date: September 2020

Study information

• Verified date: May 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Injury
• Knee Injuries
• Osteoarthritis
• Wounds and Injuries

Intervention

Other:
• Non-interventional

Locations

Country	Name	City	State
United Kingdom	Kennedy Institute of Rheumatology, University of Oxford	Oxford	Oxfordshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Oxford	BUPA Cromwell Hospital, London, UK, Fortius Clinic, Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years	Summary score for KOOS questionnaire	2 years
Secondary	Change from baseline in Kellgren Lawrence grade at 2 years	measured on X ray both knees	2 years
Secondary	Change from baseline in Whole Organ MRI Score (WORMS) at 2 years	measured on MRI both knees	2 years
Secondary	Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years	validated activity questionnaire	2 years
Secondary	Change from baseline in KOOS-4 score at 3 months	Summary score for KOOS questionnaire	3 months
Secondary	Change from baseline in KOOS-4 score at 5 years	Summary score for KOOS questionnaire	5 years
Secondary	Change from baseline in Kellgren Lawrence grade at 5 years	measured on X ray both knees	5 years
Secondary	Change from baseline in MRI WORMS score at 5 years	Measured on MRI both knees	5 years

External Links

•   Kennedy OA Centre homepage