Imperial Knee Health Cohort: New Exploration of Early-stage Changes Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
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. Those 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:
- 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.
- Clinical data collection at baseline:
Participants will complete study Core Questionnaire Pack. These are questionnaires asking about their 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 they will be asked about any knee surgeries on the affected knee, since their 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.
We 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.
详细描述
We are studying 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, but we don't know why.
Current treatments are often reactive, meaning doctors wait until the disease is advanced before they do much. This study is designed to help us better predict this process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline and 2 years
Collected via study questionnaires completed by participants.
次要结局
- Tegner Activity Score (TAS)(Baseline and minimum at 2 years/maximum 5 years)
- Post enrolment surgical intervention data (arthroplasty)(Years 1-5)
- X-ray radiographs of the index knee(Baseline and 2 years)