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临床试验/NCT02432170
NCT02432170已完成不适用

Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe

University of Washington1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Severity of Arthritis (assessed through reading radiologic images and through a pain survey)

研究概览

简要总结

This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as an imaging technique to assess arthritis in the foot and ankle.

详细描述

The overall goal of this study is to improve radiologic evaluation of foot and ankle arthritis. Today's standard of care, radiography, provides limited two-dimensional evaluation of joint alignment, arthritic changes, posttraumatic changes, and congenital deformities due to overlapping bone densities. Evaluation is even more limited in post-surgical patients due to overlapping metallic hardware. Computed tomography (CT), the current problem-solving tool, offers more "level-by-level" three dimensional information, but is fraught with additional cost, additional radiation dose, beam-hardening artifacts from hardware, and the need for additional equipment. Most importantly, patients are not weight-bearing during conventional CT, therefore masking the true extent of malalignment or arthritic joint space narrowing. At the University of Washington, physicians attempt to overcome the last problem by performing simulated weight-bearing CT. The study proposes an alternate solution to this problem using a novel application of an old method, digital tomosynthesis. Specific aims of the study are 1) to compare radiography, tomosynthesis, and simulated-weight bearing CT in their ability to detect foot/ankle malalignment, 2) to compare the abilities of these three modalities to detect arthritis changes such as joint space narrowing, osteophytes, and subchondral cysts, and 3) to compare their abilities to detect bony deformities such as acute fracture, old fracture deformity, or partial fusion (post traumatic or post surgical). Radiographic assessment will be correlated with clinical outcome using clinical notes and functional outcome such as the Lower Extremity Functional Scale (LEFS) questionnaire. Successful results from this initial study will have the potential to change practice paradigm in how to image foot and ankle arthritis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •adult age (18 years or older)
  • •clinical orthopedic surgery follow-up notes available at University of Washington
  • •ability to complete the Lower Extremity Functional Scale (LEFS) or equivalent questionnaire at the time of the study, a well established survey to test for functional ability in lower extremity

排除标准

  • •inability to use the simulated weight bearing CT machine due to pain
  • •prior complete osseous fusion of foot/ankle joints
  • •prior total ankle arthroplasty

研究组 & 干预措施

Foot/Ankles imaged with tomosynthesis

Experimental

Intervention: Digital Tomosynthesis of Foot and Ankle

The intervention, digital tomosynthesis of the foot and ankle, will be done on eligible participants. The resulting images will be compared to radiography and weight-bearing CT images from the same participants.

干预措施: Digital Tomosynthesis of Foot and Ankle (Device)

结局指标

主要结局

Severity of Arthritis (assessed through reading radiologic images and through a pain survey)

时间窗: One day

Severity of arthritis will be assessed through reading radiologic images and through a pain survey filled out by participants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Ha

Associate Professor, Radiology

University of Washington

研究点 (1)

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