A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Sensitivity for detection of significant fractures
研究概览
简要总结
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.
详细描述
Patients with ankle trauma frequently present in the emergency department. In many institutions radiographies of the ankle and foot are obtained in most of these patients, although significant fractures occur only in 15%. Therefore clinical decision rules were developed to clinically rule out significant ankle fractures, thereby reducing the number of radiographies resulting in significant time and cost savings.
Up until now the Ottawa Ankle and Foot Rules are the only clinical decision rules for ankle trauma that are widely accepted. They have a high sensitivity for the detection of fractures but a relatively low specificity. This led to the development of alternative clinical decision rules claiming equally high sensitivity but improved specificity. These alternatives have mostly not been replicated nor have they been directly compared.
This is what the researchers want to do in this study: compare different clinical decision rules regarding sensitivity and specificity. Radiographies of ankle and foot made for every patient are used as the gold standard for the detection of fractures.
Different clinical decision rules will be compared in a pediatric (5-15 years) and an adult population (from 16 years onwards). The researchers consider a clinical decision rule acceptable of it has a sensitivity of at least 95% and a specificity of at least 25%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain due to blunt trauma to the ankle
- •Must be at least 5 years old
排除标准
- •Skin defects in the injured area
- •Time of trauma > 72 hours before presentation
- •Multiple significant injuries making clinical examination impossible
- •Clinically obvious fracture
- •Re-evaluation
- •Referred with radiography
- •Result of radiography already known to investigator
- •Glasgow Coma Scale < 15
研究组 & 干预措施
Adults
Patients from 16 years of age onwards
干预措施: Ottawa Ankle and Foot Rules (Procedure)
Adults
Patients from 16 years of age onwards
干预措施: Buffalo Rule (Procedure)
Adults
Patients from 16 years of age onwards
干预措施: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia (Procedure)
Adults
Patients from 16 years of age onwards
干预措施: Thompson Test (Procedure)
Adults
Patients from 16 years of age onwards
干预措施: Palpation of the fibula (Procedure)
Adults
Patients from 16 years of age onwards
干预措施: Bernese Ankle Rules (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Ottawa Ankle and Foot Rules (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Buffalo Rule (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Thompson Test (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Ottawa Ankle and Foot Rules + swelling of the distal fibula (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Palpation of the fibula (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Ottawa Ankle and Foot Rules + palpation of the cuboid bone (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Malleolar Zone Algorithm (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Low Risk Exam (Procedure)
Children
Patients aged 5 to 15 years
干预措施: Bernese Ankle Rules (Procedure)
结局指标
主要结局
Sensitivity for detection of significant fractures
时间窗: At the first visit to the emergency department
* In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography * In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures.
Specificity for detection of significant fractures
时间窗: At the first visit to the emergency department
* In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography * In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures.
次要结局
- Prevalence of proximal fibula fractures in ankle trauma(At the first visit to the emergency department)
- Prevalence of gastrocnemius tendon rupture in ankle trauma(At the first visit to the emergency department)