Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Low Dose CT Images of Sufficient Diagnostic Quality
研究概览
简要总结
This study is a prospective, departmental funded study examining the outcomes of Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University with a Distal Radius Fracture.
详细描述
The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a low dose computed tomography scan (L-CT) in the assessment of articular displacement, and development of a treatment plan for intraarticular distal radius fractures in an effort to reduce the radiation exposure to future patients with this injury pattern. Reviewers will be tasked with reporting data aimed at investigating 3 primary outcome measures: 1) Are L-CT images of sufficient quality to be used for diagnostic purposes, 2) Can accurate measurements of step and gap displacement be made on L-CT images, 3) Do proposed treatment plans change with the use of L-CT relative to those chosen based on C-CT images We hypothesize that reviewers will find L-CT images of sufficient image quality for diagnostic purposes, measurements of step and gap displacement will not be significantly different between L-CT and C-CT, and no significant differences in treatment options will be chosen based on the use of L-CT rather than C-CT for the same fracture. The secondary aim will be to evaluate the interobserver and intraobserver reliability of L-CT in evaluating intraarticular fractures of the distal radius.
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
- •Subjects must be age 18 years or older.
- •Subject must have sustained an intraarticular distal radius fracture which undergo closed reduction and application of a below-elbow splint.
- •Subjects whos injury occurred less than 2 weeks prior to the time of enrollment.
排除标准
- •Subject is under the age of 18 years.
- •Subject is unable to speak English for completion of consent process.
- •Subject sustained pathologic fracture.
- •Subject sustained open fracture.
- •Subject is a pregnant woman.
结局指标
主要结局
Low Dose CT Images of Sufficient Diagnostic Quality
时间窗: 12 months.
Low Dose CT Images will be compared to a standard dose to assess image quality.
次要结局
- Gap Displacement(12 months)
- Step Displacement(12 months)
