OsteoarthritisKICKNCT02667756
Predicting Osteoarthritis Risk Following Knee Injury.
An observational study of Osteoarthritis and Injury, run by University of Oxford at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Osteoarthritis, Injury
- What is being tested?
- Non-interventional
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Not consenting, or contraindication to provide blood samples:
- Bilateral mastectomy
- Bilateral fistulae for renal dialysis
- Unable to give informed written consent in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kennedy Institute of Rheumatology, University of Oxford
Oxford, Oxfordshire, OX3 7FY
About this study
Official title: Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study
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)).
- Conditions
- Osteoarthritis, Injury
- Being tested
- Non-interventional
- Keywords
- biomarker, inflammation, prognosis, knee
- Medical subject headings
- Osteoarthritis, Wounds and Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
Summary score for KOOS questionnaire
Measured: 2 years
Secondary outcomes (7)
Change from baseline in Kellgren Lawrence grade at 2 years
measured on X ray both knees
Measured: 2 years
Change from baseline in Whole Organ MRI Score (WORMS) at 2 years
measured on MRI both knees
Measured: 2 years
Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years
validated activity questionnaire
Measured: 2 years
Change from baseline in KOOS-4 score at 3 months
Summary score for KOOS questionnaire
Measured: 3 months
Change from baseline in KOOS-4 score at 5 years
Summary score for KOOS questionnaire
Measured: 5 years
Change from baseline in Kellgren Lawrence grade at 5 years
measured on X ray both knees
Measured: 5 years
Change from baseline in MRI WORMS score at 5 years
Measured on MRI both knees
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJun 2010
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Fortius Clinic, BUPA Cromwell Hospital, London, UK
- Responsible party
- Sponsor
- Investigators
- Fiona Watt, MD, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667756
- Sponsor's protocol ID
- cro1532
- Other IDs
- 10/H0805/39
- Acronym
- KICK
- Status last verified
- May 2018
- First submitted
- 20 Jan 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34476411
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study
- ClinicalTrials.gov ID
- NCT02667756
- Acronym / sponsor ID
- KICK / cro1532
- Conditions
- Osteoarthritis, Injury
- Keywords
- biomarker, inflammation, prognosis, knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Fortius Clinic, BUPA Cromwell Hospital, London, UK
- Study start
- Jun 2010
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional | Other | – |
Primary outcome
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
Time frame: 2 years
Summary score for KOOS questionnaire
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 34476411Garriga 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.
- Kennedy OA Centre homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Watt, MD, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Injury, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.