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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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