Looking for blood and joint markers of knee osteoarthritis getting worse
Studies markers and genes linked to worsening knee osteoarthritis in adults, including after knee injury.
Key facts
- Who runs it
- Imperial College London
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 14 Sept 2026
- Expected to end
- 31 Jul 2031
- Type of study
- Observational, 2 groups
- Record updated
- 6 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with early-stage knee osteoarthritis, a worn (degenerative) meniscus tear, or a past serious knee injury. It follows one knee for up to 5 years with questionnaires, samples and X-rays.
- Age
- 18 years and older. People joining because of a past knee injury must have had the injury at age 50 or younger.
- Sex
- Male and female
- Disease stage
- One of these: knee osteoarthritis that is not advanced (KL grade 0-2 where an X-ray grade is available); a painful degenerative meniscal tear; probable early knee osteoarthritis without clear imaging changes (age 45 or over, knee pain with activity, no morning stiffness or stiffness under 30 minutes); or a serious knee injury in the past, confirmed by imaging or surgery.
- Earlier treatment
- No knee replacement of the studied knee. No surgery on that knee in the last 3 months. No steroid use, by mouth or by injection into that knee, in the last 3 months. No immunosuppressive drugs or chemotherapy in the last 12 months.
Main reasons for not taking part
- Advanced knee osteoarthritis on imaging (KL grade 3-4) or similar findings on MRI
- Knee replacement of the studied knee done, planned, or expected within the next 12 months
- Infection or cancer in the studied knee or the bone around it
- Inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, gout or inflammatory bowel disease, or a body-wide infection
- Pregnant or expecting to be pregnant near the Year 2 or Year 3 X-ray visit
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- ALL participants must meet the following criteria:
- Male or female, aged ≥18 years of age AND at least one of the following (a-d):; 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); A symptomatic degenerative meniscal tear with or without definite imaging findings suggesting knee osteoarthritis; 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; 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
Who cannot take part
- 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
- Surgery to the index knee in the last 3 months
- 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
- Other clinically significant knee pathology such as infection or malignancy affecting the index knee joint or surrounding bone (at any time)
- Any other systemic inflammatory disease (e.g. inflammatory bowel disease), systemic infection, or inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, gout)
- 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
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Individuals with early-stage knee osteoarthritis (or degenerative meniscal tear).
Males and females aged ≥18.
- Individuals with prior proven acute knee injury.
Males and females must be aged ≤ 50.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Imperial Knee Health Cohort: New Exploration of Early-stage Changes Study.
- Plain-language title
- Looking for blood and joint markers of knee osteoarthritis getting worseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 6 November 2026