Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-03 @ 8:46 AM
Study NCT ID:
NCT02667756
Status:
UNKNOWN
Last Update Posted:
2018-05-03
First Post:
2016-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Osteoarthritis Risk Following Knee Injury.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years', 'timeFrame': '2 years', 'description': 'Summary score for KOOS questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Kellgren Lawrence grade at 2 years', 'timeFrame': '2 years', 'description': 'measured on X ray both knees'}, {'measure': 'Change from baseline in Whole Organ MRI Score (WORMS) at 2 years', 'timeFrame': '2 years', 'description': 'measured on MRI both knees'}, {'measure': 'Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years', 'timeFrame': '2 years', 'description': 'validated activity questionnaire'}, {'measure': 'Change from baseline in KOOS-4 score at 3 months', 'timeFrame': '3 months', 'description': 'Summary score for KOOS questionnaire'}, {'measure': 'Change from baseline in KOOS-4 score at 5 years', 'timeFrame': '5 years', 'description': 'Summary score for KOOS questionnaire'}, {'measure': 'Change from baseline in Kellgren Lawrence grade at 5 years', 'timeFrame': '5 years', 'description': 'measured on X ray both knees'}, {'measure': 'Change from baseline in MRI WORMS score at 5 years', 'timeFrame': '5 years', 'description': 'Measured on MRI both knees'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biomarker', 'inflammation', 'prognosis', 'knee'], 'conditions': ['Osteoarthritis', 'Injury']}, 'referencesModule': {'references': [{'pmid': '34476411', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://oacentre.kennedy.ox.ac.uk/', 'label': 'Kennedy OA Centre homepage'}]}, 'descriptionModule': {'briefSummary': '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).\n\n150 individuals will be followed over 5 years with clinical assessment including validated questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance imaging (MRI)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically significant acute knee injury within 8 weeks of recruitment\n* Aged 16-50\n* Knee effusion, evident clinically or by MRI\n* Evidence on MRI of structural injury (from list of relevant injuries)\n* Informed written consent\n\nExclusion Criteria:\n\n* Knee injured more than 8 weeks prior to recruitment\n* Pre-existing advanced radiographic OA (Kellgren Lawrence (KL) grade 3-4) of same side knee at baseline\n* Known history of inflammatory/septic arthritis of same side knee\n* Knee replacement - previous or planned within 2 years of study start\n* Active other (treated) inflammatory disease or infection\n* Positive pregnancy test\n* Not consenting, or contraindication to provide blood samples:\n\n * Bilateral mastectomy\n * Bilateral fistulae for renal dialysis\n* Unable to give informed written consent in English'}, 'identificationModule': {'nctId': 'NCT02667756', 'acronym': 'KICK', 'briefTitle': 'Predicting Osteoarthritis Risk Following Knee Injury.', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study', 'orgStudyIdInfo': {'id': 'cro1532'}, 'secondaryIdInfos': [{'id': '10/H0805/39', 'type': 'OTHER', 'domain': 'NRES'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-interventional', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7FY', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Kennedy Institute of Rheumatology, University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Fiona Watt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, {'name': 'Fortius Clinic', 'class': 'OTHER'}, {'name': 'BUPA Cromwell Hospital, London, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}