NCT02667756

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)).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

10.3 years

First QC Date

January 20, 2016

Last Update Submit

May 2, 2018

Conditions

OsteoarthritisInjury

Keywords

biomarkerinflammationprognosisknee

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years

    Summary score for KOOS questionnaire

    2 years

Secondary Outcomes (7)

  • Change from baseline in Kellgren Lawrence grade at 2 years

    2 years

  • Change from baseline in Whole Organ MRI Score (WORMS) at 2 years

    2 years

  • Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years

    2 years

  • Change from baseline in KOOS-4 score at 3 months

    3 months

  • Change from baseline in KOOS-4 score at 5 years

    5 years

  • +2 more secondary outcomes

Interventions

Non-interventionalOTHER

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Institute of Rheumatology, University of Oxford

Oxford, Oxfordshire, OX3 7FY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34476411DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples include blood (plasma, serum, whole blood RNA, and where consent given, DNA), urine and where undergoing a relevant clinical procedure to allow sampling, synovial fluid.

MeSH Terms

Conditions

OsteoarthritisWounds and InjuriesInflammation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fiona Watt, MD, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 29, 2016

Study Start

June 1, 2010

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)