Predicting Osteoarthritis Risk Following Knee Injury.

University of Oxford150 enrolled

Overview

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)).

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Osteoarthritis Injury

Interventions

Non-interventionalOTHER

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Kennedy Institute of Rheumatology, University of Oxford

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

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

Summary score for KOOS questionnaire

Time frame: 2 years

Secondary Outcomes

Change from baseline in Kellgren Lawrence grade at 2 years

measured on X ray both knees

Time frame: 2 years

Change from baseline in Whole Organ MRI Score (WORMS) at 2 years

measured on MRI both knees

Time frame: 2 years

Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years

validated activity questionnaire

Time frame: 2 years

Change from baseline in KOOS-4 score at 3 months

Summary score for KOOS questionnaire

Time frame: 3 months

Change from baseline in KOOS-4 score at 5 years

Summary score for KOOS questionnaire

Time frame: 5 years

Change from baseline in Kellgren Lawrence grade at 5 years

measured on X ray both knees

Time frame: 5 years

Change from baseline in MRI WORMS score at 5 years

Measured on MRI both knees

Time frame: 5 years

Data from ClinicalTrials.gov

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