Can we 'Hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of POCUS
研究概览
简要总结
Hip (femoral neck and pertrochanteric) fractures account for a significant part of Emergency Department (ED) visits after trauma. Studies suggest that point-of-care ultrasound (POCUS) is a reliable diagnostic tool for fracture assessment. POCUS has several advantages over conventional radiography, such as being portable, cheaper and radiation free. In addition, immediate conversion to ultrasound guided regional anaesthesia upon diagnosis of fracture can improve patient's time to proper analgesia. Moreover, POCUS can potentially be used pre-hospital to rule out hip fractures reducing ED crowding, as well as being a solution for areas where radiography is not readily available (e.g. rural or developing areas).
The primary objective of this study, is to evaluate the diagnostic capabilities of POCUS regarding patients with suspected hip fracture after trauma compared to radiography, the current standard of care diagnostic tool.
详细描述
Rationale: Hip (femoral neck and pertrochanteric) fractures account for a significant part of Emergency Department (ED) visits after trauma. Studies suggest that point-of-care ultrasound (POCUS) is a reliable diagnostic tool for fracture assessment. POCUS has several advantages over conventional radiography, such as being portable, cheaper and radiation free. In addition, immediate conversion to ultrasound guided regional anaesthesia upon diagnosis of fracture can improve patient's time to proper analgesia. Moreover, POCUS can potentially be used pre-hospital to rule out hip fractures reducing ED crowding, as well as being a solution for areas where radiography is not readily available (e.g. rural or developing areas).
Objective: Our primary objective is to evaluate the diagnostic capabilities of POCUS regarding patients with suspected hip fracture after trauma compared to radiography, the current standard of care diagnostic tool.
Study design: Prospective cohort study. Study population: All patients aged 18 and older presenting to the ED with a painful hip after trauma suspected of hip fracture are eligible to be enrolled in this study.
Intervention: Patients enrolled in the study will undergo POCUS of the hip (femoral neck) by the (resident) emergency physician, prior to radiograph imaging.
Main study parameters/endpoints: Sensitivity, specificity, positive predicting value (PPV) and negative predicting value (NPV) of POCUS in detecting hip fractures by assessing for posttraumatic changes (cortical disruptions, joint effusion and peritrochanteric edema).
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
- •≥18 years of age
- •presenting to the ED with a painful hip after trauma, suspected of hip fracture as defined by the attending clinician
排除标准
- •History of hip fracture or surgical procedure on the bones of the ipsilateral hip (ultrasound images may be unreliable)
- •Presence of foreign body material in the ipsilateral hip
- •Skin defects at the POCUS site e.g. lacerations, infected skin
- •Extensive injuries, extreme pain or neurovascular damage where urgent intervention is required
- •Inability to give informed consent (cognitive impairments, no proficient understanding of the Dutch or English language)
研究组 & 干预措施
All participants
All patients enrolled in the study will undergo POCUS of the hip by the (resident) emergency physician, prior to radiograph imaging.
干预措施: POCUS of the hip (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of POCUS
时间窗: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in detecting hip fractures by assessing for posttraumatic changes (cortical disruptions, joint effusion and peritrochanteric edema).
次要结局
- Difference in diagnostic accuracy of POCUS in diagnosing a femoral neck or pertrochanteric fracture(From enrollment to the end of POCUS, approximately 10 to 30 minutes)
- Difference in diagnostic accuracy of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS(From enrollment to the end of POCUS, approximately 10 to 30 minutes)
- Difference in effusion measured in mm between the ipsilateral and contralateral hip(From enrollment to the end of POCUS, approximately 10 to 30 minutes)
- Added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician(From enrollment to the end of POCUS, approximately 10 to 30 minutes)
研究者
Svenja Haak
MD
Frisius Medisch Centrum
