Clinical trial NCT02667756: Predicting Osteoarthritis Risk Following Knee Injury.
Official title: Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Injury
Keywords: biomarker
inflammation
prognosis
knee
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Fortius Clinic
name: BUPA Cromwell Hospital, London, UK
First posted: 2016-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a non-intervention cohort study of subjects who have recently sustained a structural knee injury. Individuals are identified from the practice of a collaborating surgeon (AW) at a number of London sites, several of which are within private practice. Because of the practice of the surgeon investigator, a large number will be sporting professionals, or playing amateur sport at a high level.

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)).


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

Primary outcomes:
measure: Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Change from baseline in Kellgren Lawrence grade at 2 years
timeFrame: 2 years
measure: Change from baseline in Whole Organ MRI Score (WORMS) at 2 years
timeFrame: 2 years
measure: Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years
timeFrame: 2 years
measure: Change from baseline in KOOS-4 score at 3 months
timeFrame: 3 months
measure: Change from baseline in KOOS-4 score at 5 years
timeFrame: 5 years
measure: Change from baseline in Kellgren Lawrence grade at 5 years
timeFrame: 5 years
measure: Change from baseline in MRI WORMS score at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Kennedy Institute of Rheumatology, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Fiona Watt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garriga C, Goff M, Paterson E, Hrusecka R, Hamid B, Alderson J, Leyland K, Honeyfield L, Greenshields L, Satchithananda K, Lim A, Arden NK, Judge A, Williams A, Vincent TL, Watt FE. Clinical and molecular associations with outcomes at 2 years after acute knee injury: a longitudinal study in the Knee Injury Cohort at the Kennedy (KICK). Lancet Rheumatol. 2021 Jun 24;3(9):e648-e658. doi: 10.1016/S2665-9913(21)00116-8. eCollection 2021 Sep.