Overview

This trial is active, not recruiting.

Conditions osteoarthritis, injury
Treatment non-interventional
Sponsor University of Oxford
Collaborator Imperial College Healthcare NHS Trust
Start date June 2010
End date February 2017
Trial size 150 participants
Trial identifier NCT02667756, 10/H0805/39, cro1532

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)).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

Secondary Outcomes

Measure
Change from baseline in Kellgren Lawrence grade at 2 years
time frame: 2 years
Change from baseline in Whole Organ MRI Score (WORMS) at 2 years
time frame: 2 years
Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years
time frame: 2 years
Change from baseline in KOOS-4 score at 3 months
time frame: 3 months
Change from baseline in KOOS-4 score at 5 years
time frame: 5 years
Change from baseline in Kellgren Lawrence grade at 5 years
time frame: 5 years
Change from baseline in MRI WORMS score at 5 years
time frame: 5 years

Eligibility Criteria

Male or female participants from 16 years up to 50 years old.

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

Additional Information

Official title Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study
Principal investigator Fiona Watt, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Oxford.