[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657149":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":69,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":25,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":101,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Imperial College London","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Knee injury and Osteoarthritis Outcome Score (KOOS)","Collected via study questionnaires completed by participants. Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific self-reported instrument, developed to assess participant's opinions about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and osteoarthritis. It holds 42 items in 5 separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation, and knee-related Quality of Life.\n\nThe KOOS is scored from 0 to 100, where higher scores indicate a better outcome, representing fewer symptoms and better knee-related quality of life.","Baseline and 2 years",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Tegner Activity Score (TAS)","Collected via study questionnaires completed by participants.\n\nTegner Activity Score (TAS) is a rating system that measures participant's physical activity level on a scale from 0 to 10, where 0 indicates being on sick leave due to knee problems, and 10 represents participation in competitive sports at an elite or professional level (with higher scores indicating greater physical activity and sports participation).","Baseline and minimum at 2 years\u002Fmaximum 5 years",{"measure":19,"description":20,"timeFrame":21},"Post enrolment surgical intervention data (arthroplasty)","Collected via study questionnaires completed by participants to track the incidence and type of subsequent knee surgeries. This outcome measures the occurrence of an event (such as whether a surgical intervention took place, and if so what was the date of the intervention).","Years 1-5",{"measure":23,"description":24,"timeFrame":12},"X-ray radiographs of the index knee","Evaluation of joint space narrowing in the tibio-femoral and patello-femoral joints, and the presence of osteophyte formation, using the Kellgren-Lawrence scale, a widely accepted method of assessing radiographic osteoarthritis.\n\nThe Kellgren-Lawrence scale ranges from grade 0 to 4, where grade 0 indicates no osteoarthritis changes and grade 4 represents the most severe degree of joint degeneration.",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","The study aims to identify people who are in the early-stage of knee osteoarthritis or at risk of knee osteoarthritis. The current course of osteoarthritis is quite unpredictable. Early on symptoms (and structural changes) can get worse or can get better, yet the exact etiology remains unclear. Current treatments are often reactive, meaning doctors wait until the disease is advanced before they do much. This study is designed to help better predict this process.","Participants will be recruited across Imperial College Healthcare NHS Trust (ICHNT) through four primary pathways:\n\n1. Elective Orthopaedic Lists:\n\n   Patients scheduled for relevant procedures on elective orthopaedic surgical lists.\n2. Outpatient Procedural Lists:\n\n   Patients scheduled for joint drainage or intra-articular injections within musculoskeletal specialties, including rheumatology, sports and exercise medicine, and musculoskeletal radiology.\n3. Participants from existing research cohorts, such as the Imperial College Healthcare Tissue Bank (ICHTB), i.e., i-Bank, who are eligible and have previously consented to be re-contacted for future studies.\n4. Research Registries:\n\nIndividuals identified via research registries and mailing lists, including the Imperial Joint Health: Understanding, Monitoring and Prevention (JUMP) Registry, the Northwest London Health Research Register, and the Imperial Health Knowledge Bank (IHKB).",[32,35],{"label":33,"type":25,"description":34,"interventionNames":25},"Individuals with early-stage knee osteoarthritis (or degenerative meniscal tear).","Males and females aged ≥18.",{"label":36,"type":25,"description":37,"interventionNames":25},"Individuals with prior proven acute knee injury.","Males and females must be aged ≤ 50.",[39],{"name":40,"affiliation":5,"role":41},"Fiona Watt, Dr","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Fiona Watt","CONTACT","+44 07858 367326","f.watt@imperial.ac.uk",{"name":49,"role":45,"phone":46,"phoneExt":25,"email":50},"Malgorzata Kochanska","oaresearchgroup@imperial.ac.uk",[52],{"facility":53,"status":25,"city":54,"state":25,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Centre for Inflammatory Disease, 9th Floor, Commonwealth Building, Imperial College London, Department of Immunology and Inflammation, Hammersmith Campus, Du Cane Road, London","London","W12 0NN","United Kingdom","UK",{"type":59,"coordinates":60},"Point",[61,62],-0.12574,51.50853,{"lat":62,"lon":61},[65,66,68],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},{"name":49,"role":45,"phone":46,"phoneExt":67,"email":50},"+44 07858 3673",{"name":44,"role":41,"phone":25,"phoneExt":25,"email":25},{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[72,75],{"name":73,"class":74},"Arthritis UK","UNKNOWN",{"name":76,"class":6},"UK Research and Innovation","100657149","exploring-factors-linked-to-worsening-over-time-in-people-with-early-stage-knee-osteoarthritis-and-those-with-prior-proven-acute-knee-injury-100657149",false,"NCT07833488","Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.","Imperial Knee Health Cohort: New Exploration of Early-stage Changes Study.","KNEE","Inclusion Criteria:\n\nALL participants must meet the following criteria:\n\n* Male or female, aged ≥18 years of age AND at least one of the following (a-d):\n\n  1. A definite diagnosis of knee osteoarthritis , evidenced by consistent knee symptoms and imaging findings, commensurate with non-advanced KL grade changes (KL 0-2 where an X-ray grade is available)\n  2. A symptomatic degenerative meniscal tear with or without definite imaging findings suggesting knee osteoarthritis\n  3. Probable early-stage symptomatic knee osteoarthritis without definite imaging changes, fulfilling NICE diagnostic criteria for osteoarthritis:\n\n     * Age 45 or over\n     * Activity-related knee pain.\n     * Either no morning stiffness or that lasts \\\u003C30 minutes\n  4. A definite clinically significant acute knee injury at the age of 50 or younger at any stage in the past, evidenced by appropriate clinical history of a traumatic knee episode AND documented imaging or surgical confirmation of a relevant structural injury.\n* Willing to provide at least one of the following samples: synovial fluid or blood (a salivary sample is an acceptable alternative for remote participants with a history of knee injury. This alternative also applies to existing participants from ICHTB\u002FIHKB, for whom no prior DNA sample is currently banked)\n* Understand English sufficiently to be able to read PIS, ICF and\u002For Participant Invitation Letter\n* Provide an ICF, signed by the participant\n* Be capable of complying with Protocol requirements, i.e. completing study questionnaire packs.\n\nExclusion Criteria:\n\n* Known advanced radiographic changes of KOA on available imaging (KL grade 3-4 where available), or other commensurate findings, such as those present on MRI\n* Knee joint replacement (uni-compartmental arthroplasty or total knee arthroplasty) of the index knee, prior to consent, or planned during current episode of care, or within next 12 months\n* Other clinically significant knee pathology such as infection or malignancy affecting the index knee joint or surrounding bone (at any time)\n* Surgery to the index knee in the last 3 months\n* Any other systemic inflammatory disease (e.g. inflammatory bowel disease), systemic infection, or inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, gout)\n* Systemic\u002Fintra-articular steroid use to index knee in the last 3 months\n* Any use of immunosuppressive drugs or chemotherapy in the last 12 months\n* Unwilling or unable to provide follow-up data for minimum 2 years and\u002For maximum 5 years\n* Pregnancy, expecting to be pregnant, near the scheduled Year 2 or Year 3 X-ray visit.\n* Other medical reason which would prevent participation, at the discretion of the investigator.","ALL","18 Years",{"count":88,"type":89},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational, non-interventional cohort study is to identify tests or markers in blood or knee fluid, or any genetic risk factors that might contribute to worsening or improvement of knee osteoarthritis.\n\nMales and females aged ≥18 with early-stage knee osteoarthritis, prior proven acute knee injury, or degenerative meniscal tear will be recruited at Imperial College Healthcare NHS Trust. Participants with prior proven acute knee injury must be aged ≤ 50. A single knee per participant will be followed throughout the study; this will be referred to as ''affected knee'', identified at baseline.\n\nThe study involves:\n\n1. Samples collection:\n\n   * From individuals recruited in-person: blood or buccal (cheek) swab and\u002For knee joint (synovial) fluid - this will be collected during routine NHS visit, if individuals undergo scheduled knee surgery or knee aspiration procedure (Knee aspiration is a procedure to remove excess fluid from the knee joint for diagnosis or treatment).\n   * From individuals recruited remotely: saliva sample.\n2. Clinical data collection at baseline:\n\n   Participants will complete study Core Questionnaire Pack. These are questionnaires asking about participants' knee pain, function, and activity level.\n3. Clinical data collection at yearly remote visits, through years 1-5:\n\n   Participants will complete study Follow-Up Questionnaire Pack, asking about participants' knee pain, function, and activity level - same as at baseline, but additionally participants will be asked about any knee surgeries on the affected knee, since the last study visit.\n4. Imaging data collection at baseline and at Year 2 or Year 3 follow-up visit:\n\nIf at baseline visit X-ray imaging is available as a part of usual NHS care, then participants will only be invited to attend one X-ray appointment at Year 2 or Year 3 follow-up visit.\n\nThe study expect to recruit up to 200 participants with approximately 100 participants having early-stage knee osteoarthritis or degenerative meniscal tear and the remaining participants having prior proven acute knee injury.\n\nIndividuals will be able join the study for between 2-3 years. Follow up visits will last up to 5 years.",[93],"Knee Osteoarthritis",[95,96,97,98,99,100],"post-traumatic knee osteoarthritis","genetics","synovial fluid","protein marker","knee injury","knee","NOT_YET_RECRUITING","2026-09-23",{"date":104,"type":105},"2026-09-28","ACTUAL",{"date":107,"type":89},"2026-09",{"date":109,"type":89},"2031-07-31",{"name":5,"class":6},1]