Predicting Osteoarthritis Risk Following Knee Injury.

Study 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)).

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

Conditions
-----------------
Osteoarthritis, Injury

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-interventional|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years | Summary score for KOOS questionnaire | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, inflammation, prognosis, knee