Predicting Osteoarthritis Risk Following Knee Injury.

• Conditions: Osteoarthritis; Injury

• Registration Number: NCT02667756
• Lead Sponsor: University of Oxford

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)).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years	2 years	Summary score for KOOS questionnaire

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Whole Organ MRI Score (WORMS) at 2 years	2 years	measured on MRI both knees
Change from baseline in MRI WORMS score at 5 years	5 years	Measured on MRI both knees
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 KOOS-4 score at 3 months	3 months	Summary score for KOOS questionnaire
Change from baseline in KOOS-4 score at 5 years	5 years	Summary score for KOOS questionnaire
Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years	2 years	validated activity questionnaire

Trial Locations

Locations (1)

Kennedy Institute of Rheumatology, University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom