About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Age 45 or over
Activity-related knee pain.
Disqualifiers
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
Trial 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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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).
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.
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