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临床试验/NCT01492855
NCT01492855已完成不适用

The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions

Northern Orthopaedic Division, Denmark1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
324
试验地点
1
主要终点
Investigation of improvement in KOOS subscale pain and symptoms

研究概览

简要总结

The knee menisci are two semicircular fibrocartilaginous structures located between the articular cartilage surfaces of the femur and tibia in the medial and lateral joint compartments. The main functions of the menisci are shock absorption and load transmission in the knee, mainly through distribution of mechanical stress over a large area of the joint cartilage.

The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline are associated with poorer outcome.

详细描述

Meniscal lesions are the most common source of disability of the knee with a reported incidence rate of up to 18 meniscal lesions per 10.000 subjects per year in Denmark. The meniscus may tear as a result of knee trauma or it may tear spontaneously due to aging and degenerative processes. Magnetic resonance imaging (MRI) is increasingly used in the diagnosis of meniscal lesions with documented high sensitivity and specificity. Meniscal lesion symptoms vary from reduction in knee function with decreased muscle strength and difficulties in performing strenuous activities involving knee flexion and rotation to pain, effusion locking and, giving way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical suspicion of meniscal lesion according to pain on weight-bearing activities, locking, normal stability, tenderness at medial and/or lateral joint line, normal X-ray
  • Age > 18 years
  • Able to understand Danish
  • Able to sign an informed consent

排除标准

  • Age < 18 years
  • Unable to understand Danish
  • Unable to sign an informed consent
  • Unstable knee
  • X-ray or MRI that shows other diagnoses

结局指标

主要结局

Investigation of improvement in KOOS subscale pain and symptoms

时间窗: 12 months

A multiple linear regression model is constructed to investigate which pre-treatment prognostic factors are associated to improvement in KOOS subscale pain and symptoms from baseline to follow-up.

次要结局

未报告次要终点

研究者

发起方
Northern Orthopaedic Division, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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