Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
NCT Number: NCT06765083
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Leeuwarden, 8934 AD, Netherlands
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).
Informed consent will be requested and documented.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
POCUS of the hip (proximal femur) by the (resident) emergency physician, prior to radiograph imaging.
Time frame: 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).
Time frame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Difference in diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in diagnosing a femoral neck or pertrochanteric fracture
Time frame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Difference in diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS
Time frame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Difference in effusion measured in mm between the ipsilateral and contralateral hip
Time frame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Evaluate the added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician (questionnaire: hip fracture clinical suspected yes or no)
Frisius Medisch Centrum
Other
Can we 'Hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures.
Acronym: CHEFF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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