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临床试验/NCT03446404
NCT03446404已完成不适用

Standing Computerized Tomography (SCT) Imaging of the Knee Joint in People With or at Risk for Knee Osteoarthritis (KOA)

Neil A Segal1 个研究点 分布在 1 个国家目标入组 826 人开始时间: 2016年3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
826
试验地点
1
主要终点
Change in Joint Space Width

研究概览

简要总结

This study will help us decide the best way to image the knee for diagnostic purposes: Knee computed tomography vs knee x-ray. The computed tomography will provide a weight bearing 3D view.

详细描述

This will be an ancillary study to the Multicenter Osteoarthritis Study (MOST) second renewal #201511711). Using a prototype Curve Beam Standing Computed Tomography (SCT) scanner to get a 3 dimensional picture of the knee joint, bilaterally. This scanner by Curve Beam 175 Titus Ave, Suite 300, Warrington, Pennsylvania 18976, has been approved by the Food and Drug Administration (FDA) for ankles and feet. This has been modified to do the scan of the knee but is not yet approved by the FDA for the knees. The proposed ancillary study would add the key benefit of providing more sensitive and accurate identification of prevalent knee osteoarthritis (OA) at baseline and incident knee OA at follow-up than is available with plain radiographs. In addition, it would enable biomechanical modeling of the knee joint on a larger scale than achieved in any prior study, allowing testing of biomechanical hypotheses regarding mechanisms of disease development and progression that have not been possible on this scale previously.

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
45 Years 至 92 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only participants in the Multicenter Osteoarthritis Study (MOST) who attend a 0/144-month visit at the Iowa site are eligible for inclusion.
  • Additional Inclusion Criteria Include:
  • Completed knee radiograph (posteroanterior view) at 0/144-month visit of primary MOST-second renewal study at the Iowa Site

排除标准

  • Bilateral Total Knee Arthroplasty

结局指标

主要结局

Change in Joint Space Width

时间窗: Baseline and 2-years

3D measurement of distance between articular surfaces of tibia and femur

次要结局

未报告次要终点

研究者

发起方
Neil A Segal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Neil A Segal

Adjunct Professor

University of Iowa

研究点 (1)

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