Predicting Osteoarthritis Risk Following Knee Injury.

NCT ID: NCT02667756

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Fortius Clinic

OTHER

Sponsor Role collaborator

BUPA Cromwell Hospital, London, UK

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fiona Watt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Kennedy Institute of Rheumatology, University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34476411 (View on PubMed)

Related Links

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http://oacentre.kennedy.ox.ac.uk/

Kennedy OA Centre homepage

Other Identifiers

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10/H0805/39

Identifier Type: OTHER

Identifier Source: secondary_id

cro1532

Identifier Type: -

Identifier Source: org_study_id

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