ClinicalTrials.gg
RecruitingNCT07833488KNEEUpdated Nov 6, 2026

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

An observational study in Knee Osteoarthritis, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Imperial College London · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 6, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • post-traumatic knee osteoarthritis
  • genetics
  • synovial fluid
  • protein marker
  • knee injury
  • knee
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited across Imperial College Healthcare NHS Trust (ICHNT) through four primary pathways:

  1. Elective Orthopaedic Lists:

    Patients scheduled for relevant procedures on elective orthopaedic surgical lists.

  2. Outpatient Procedural Lists:

    Patients scheduled for joint drainage or intra-articular injections within musculoskeletal specialties, including rheumatology, sports and exercise medicine, and musculoskeletal radiology.

  3. 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.
  4. Research Registries:

Individuals 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 knee pathology such as infection or 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 use to index knee in the last 3 months
  • Any use of 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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. The KOOS is scored from 0 to 100, where higher scores indicate a better outcome, representing fewer symptoms and better knee-related quality of life.

    Time frame: Baseline and 2 years

Secondary outcomes

  1. Tegner Activity Score (TAS)

    Collected via study questionnaires completed by participants. Tegner 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).

    Time frame: Baseline and minimum at 2 years/maximum 5 years

  2. 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).

    Time frame: Years 1-5

  3. 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. The 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.

    Time frame: Baseline and 2 years

07

Study locations

1 of 1 sites recruiting
  • 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
    Recruiting
08

References and documents

Publications

  • Perry T, Deng Y, Hulley P, et al. Deconvoluting synovial fluid molecular endotypes in knee osteoarthritis: primary results from the STEpUP OA Consortium. medRxiv; 2024. DOI: 10.1101/2024.06.05.24308485.
  • Osteoarthritis in over 16s: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2022 Oct 19. Available from http://www.ncbi.nlm.nih.gov/books/NBK588843/ PubMed 36745715 ↗
  • Burn E, Murray DW, Hawker GA, Pinedo-Villanueva R, Prieto-Alhambra D. Lifetime risk of knee and hip replacement following a GP diagnosis of osteoarthritis: a real-world cohort study. Osteoarthritis Cartilage. 2019 Nov;27(11):1627-1635. doi: 10.1016/j.joca.2019.06.004. Epub 2019 Jun 17. PubMed 31220608 ↗
  • 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 ↗
  • Kalsoum R, Minns Lowe CJ, Gilbert S, McCaskie AW, Snow M, Wright K, Bruce G, Mason DJ, Watt FE. A mixed-methods approach exploring acceptability and feasibility of trials designed to test drugs targeting prevention of post-traumatic osteoarthritis after knee injury. Bone Joint Res. 2024 Sep 19;13(9):513-524. doi: 10.1302/2046-3758.139.BJR-2024-0109. PubMed 39293808 ↗
  • Hollis B, Chatzigeorgiou C, Southam L, Hatzikotoulas K, Kluzek S, Williams A; Genetics of Osteoarthritis Consortium; Zeggini E, Jostins-Dean L, Watt FE. Lifetime risk and genetic predisposition to post-traumatic OA of the knee in the UK Biobank. Osteoarthritis Cartilage. 2023 Oct;31(10):1377-1387. doi: 10.1016/j.joca.2023.05.012. Epub 2023 May 27. PubMed 37247657 ↗
  • Watt FE, Paterson E, Freidin A, Kenny M, Judge A, Saklatvala J, Williams A, Vincent TL. Acute Molecular Changes in Synovial Fluid Following Human Knee Injury: Association With Early Clinical Outcomes. Arthritis Rheumatol. 2016 Sep;68(9):2129-40. doi: 10.1002/art.39677. PubMed 26991527 ↗
  • Paskins Z, Farmer CE, Manning F, Andersson DA, Barlow T, Bishop FL, Brown CA, Clark A, Clark EM, Dulake D, Gulati M, Le Maitre CL, Jones RK, Loughlin J, Mason DJ, McCarron M, Millar NL, Pandit H, Peat G, Richardson SM, Salt EJ, Taylor EJ, Troeberg L, Wilcox RK, Wise E, Wilkinson C, Watt FE; Musculoskeletal Disorders Research Advisory Group Versus Arthritis. Research priorities to reduce the impact of musculoskeletal disorders: a priority setting exercise with the child health and nutrition research initiative method. Lancet Rheumatol. 2022 Jul 27;4(9):e635-e645. doi: 10.1016/S2665-9913(22)00136-9. eCollection 2022 Sep. PubMed 36275038 ↗
  • Liu Q, Chu H, LaValley MP, Hunter DJ, Zhang H, Tao L, Zhan S, Lin J, Zhang Y. Prediction models for the risk of total knee replacement: development and validation using data from multicentre cohort studies. Lancet Rheumatol. 2022 Feb;4(2):e125-e134. doi: 10.1016/s2665-9913(21)00324-6. Epub 2022 Jan 5. PubMed 36177295 ↗
  • Lo GH, Schneider E, Driban JB, Price LL, Hunter DJ, Eaton CB, Hochberg MC, Jackson RD, Kwoh CK, Nevitt MC, Lynch JA, McAlindon TE; OAI Investigators Group. Periarticular bone predicts knee osteoarthritis progression: Data from the Osteoarthritis Initiative. Semin Arthritis Rheum. 2018 Oct;48(2):155-161. doi: 10.1016/j.semarthrit.2018.01.008. Epub 2018 Jan 31. PubMed 29449014 ↗
  • Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available. PubMed 22588746 ↗
  • Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64. PubMed 14613558 ↗
  • Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006 Nov-Dec;20(10):739-44. doi: 10.1097/01.bot.0000246468.80635.ef. PubMed 17106388 ↗
  • Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29. PubMed 17761605 ↗
  • Nicholls E, Thomas E, van der Windt DA, Croft PR, Peat G. Pain trajectory groups in persons with, or at high risk of, knee osteoarthritis: findings from the Knee Clinical Assessment Study and the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2014 Dec;22(12):2041-50. doi: 10.1016/j.joca.2014.09.026. Epub 2014 Oct 8. PubMed 25305072 ↗
  • Watt FE. Posttraumatic osteoarthritis: what have we learned to advance osteoarthritis? Curr Opin Rheumatol. 2021 Jan;33(1):74-83. doi: 10.1097/BOR.0000000000000760. PubMed 33186246 ↗

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
Centre for Inflammatory Disease, 9th Floor, Commonwealth Building, Imperial College London, Department of Immunology and Inflammation, Hammersmith Campus, Du Cane Road, London is now Recruiting
Nov 6, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionKnee injury and Osteoarthritis Outcome Score (KOOS): how it is measured was reworded
Sep 28, 2026
Secondary outcomes
3 description edited
What changed in the outcomes
  • DescriptionPost enrolment surgical intervention data (arthroplasty): how it is measured was reworded
  • DescriptionTegner Activity Score (TAS): how it is measured was reworded
  • DescriptionX-ray radiographs of the index knee: how it is measured was reworded
Sep 28, 2026
Show all 2 updates
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    Centre for Inflammatory Disease, 9th Floor, Commonwealth Building, Imperial College London, Department of Immunology and Inflammation, Hammersmith Campus, Du Cane Road, London is now Recruiting
    + 2 other changes: verification date and date precision
  2. Sep 28, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionKnee injury and Osteoarthritis Outcome Score (KOOS): how it is measured was reworded
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionPost enrolment surgical intervention data (arthroplasty): how it is measured was reworded
    • DescriptionTegner Activity Score (TAS): how it is measured was reworded
    • DescriptionX-ray radiographs of the index knee: how it is measured was reworded
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07833488
Collaborators
Arthritis UK, UK Research and Innovation
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Sep 14, 2026
Primary completion
Jul 31, 2031 (estimated)
Completion
Jul 31, 2031 (estimated)
Last update
Nov 6, 2026

Study contacts

Fiona Watt
Contact
f.watt@imperial.ac.uk
+44 07858 367326
Malgorzata Kochanska
Contact
oaresearchgroup@imperial.ac.uk
+44 07858 367326
Fiona Watt, Dr
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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