Does the Biological Response to Degenerative Meniscal Tears or to Their Intervention Predict Future Osteoarthritis?: The Meniscal Tear and Osteoarthritis Risk (MenTOR) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4
研究概览
简要总结
Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this non-interventional cohort study. The aim is to investigate whether measurement of an individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 30-60 years.
- •Participant able and willing to give informed consent.
- •Clinical assessment demonstrates mechanical symptoms suggestive of meniscal pathology (focal knee pain +/- 1 or more of: catching/locking, giving way, focal joint-line tenderness, effusion, McMurray's positive) within last 12 months.
- •Evidence on clinical MRI knee of meniscal tear.
- •Participant is either in secondary care or has the potential to be referred to secondary care due to severity of symptoms.
- •Patient has failed conservative therapy and elected for surgical arthroscopic treatment, or is due knee drainage/injection for clinical reasons.
- •Competency of the English language to complete questionnaires independently.
排除标准
- •Pre-existing advanced radiographic OA (KL grade 3-4) of index knee at baseline.
- •Evidence of anterior cruciate ligament rupture, or more extensive soft tissue injury.
- •History of an acute knee injury (within 12 weeks), or acutely locked knee
- •Known history of inflammatory/septic arthritis of index knee.
- •Knee replacement or other non-arthroscopic knee surgery (e.g. high tibial osteotomy) - previous or planned within 1 year of study start.
- •Index knee surgery within last 3 months, including meniscectomy.
- •Steroid injection to index knee in last 3 months.
- •Active other (treated) inflammatory disease or infection.
- •Positive pregnancy test.
- •Unable to provide blood samples.
- •Unable to give informed written consent.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4
时间窗: 2 years
summary score from validated KOOS questionnaire. To investigate whether measurement of an individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms predicts symptomatic and functional outcome suggestive of OA of the knee.
次要结局
- Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)(2 years)
- X ray Kellgren Lawrence (KL) change(2 years)
- MRI semi-quantitative score(2 years)