Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07833488

Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

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. Males 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. The study involves: 1. Samples collection: * From individuals recruited in-person: blood or buccal (cheek) swab and/or 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). * From individuals recruited remotely: saliva sample. 2. Clinical data collection at baseline: Participants will complete study Core Questionnaire Pack. These are questionnaires asking about participants' knee pain, function, and activity level. 3. Clinical data collection at yearly remote visits, through years 1-5: 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. 4. Imaging data collection at baseline and at Year 2 or Year 3 follow-up visit: If 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. The 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. Individuals will be able join the study for between 2-3 years. Follow up visits will last up to 5 years.

Official title: Imperial Knee Health Cohort: New Exploration of Early-stage Changes Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-09

Completion Date

2031-07-31

Last Updated

2026-09-28

Healthy Volunteers

Conditions

Knee Osteoarthritis

Inclusion Criteria: ALL participants must meet the following criteria: * Male or female, aged ≥18 years of age AND at least one of the following (a-d): 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) 2. A symptomatic degenerative meniscal tear with or without definite imaging findings suggesting knee osteoarthritis 3. Probable early-stage symptomatic knee osteoarthritis without definite imaging changes, fulfilling NICE diagnostic criteria for osteoarthritis: * Age 45 or over * Activity-related knee pain. * Either no morning stiffness or that lasts \<30 minutes 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. * 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/IHKB, for whom no prior DNA sample is currently banked) * Understand English sufficiently to be able to read PIS, ICF and/or Participant Invitation Letter * Provide an ICF, signed by the participant * Be capable of complying with Protocol requirements, i.e. completing study questionnaire packs. Exclusion Criteria: * 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 * 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 * Other clinically significant knee pathology such as infection or malignancy affecting the index knee joint or surrounding bone (at any time) * Surgery to the index knee in the last 3 months * Any other systemic inflammatory disease (e.g. inflammatory bowel disease), systemic infection, or inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, gout) * Systemic/intra-articular steroid use to index knee in the last 3 months * Any use of immunosuppressive drugs or chemotherapy in the last 12 months * Unwilling or unable to provide follow-up data for minimum 2 years and/or maximum 5 years * Pregnancy, expecting to be pregnant, near the scheduled Year 2 or Year 3 X-ray visit. * Other medical reason which would prevent participation, at the discretion of the investigator.

Locations (1)

Centre for Inflammatory Disease, 9th Floor, Commonwealth Building, Imperial College London, Department of Immunology and Inflammation, Hammersmith Campus, Du Cane Road, London

London, United Kingdom