NCT02599441已完成不适用
Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Medial Clear Space Distance in the Ankle Joint
研究概览
简要总结
To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •willing & able to provide written informed consent
- •at least 18 years-old
- •have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray
排除标准
- •pregnant (females)
- •prisoners
- •open fracture
- •clinical signs of foot deformity
- •previous foot trauma or surgery on the affected foot
- •significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
- •unable to stand in the weight bearing position during the CT scan
结局指标
主要结局
Medial Clear Space Distance in the Ankle Joint
时间窗: Baseline- single-day study
measured on weight bearing CBCT
次要结局
- Medial Clear Space on Standard Xray(Baseline)
- Medial Clear Space on Gravity Stress Xray(Baseline)
研究者
John Marzo
Associate Professor of Clinical Orthopaedics
State University of New York at Buffalo
研究点 (1)
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