Injury, Osteoarthritis
Conditions
Keywords
biomarker, inflammation, prognosis, knee
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)).
Interventions
OTHERNon-interventional
Sponsors
Imperial College Healthcare NHS Trust
Fortius Clinic
BUPA Cromwell Hospital, London, UK
University of Oxford
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years | 2 years | Summary score for KOOS questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Whole Organ MRI Score (WORMS) at 2 years | 2 years | measured on MRI both knees |
| Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years | 2 years | validated activity questionnaire |
| Change from baseline in KOOS-4 score at 3 months | 3 months | Summary score for KOOS questionnaire |
| Change from baseline in Kellgren Lawrence grade at 2 years | 2 years | measured on X ray both knees |
| Change from baseline in Kellgren Lawrence grade at 5 years | 5 years | measured on X ray both knees |
| Change from baseline in MRI WORMS score at 5 years | 5 years | Measured on MRI both knees |
| Change from baseline in KOOS-4 score at 5 years | 5 years | Summary score for KOOS questionnaire |
Countries
United Kingdom
Outcome results
None listed