Can We 'hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrisius Medisch Centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
presenting to the ED with a painful hip after trauma, suspected of hip fracture as defined by the attending clinician
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
POCUS of the hip
Diagnostic testPOCUS of the hip (proximal femur) by the (resident) emergency physician, prior to radiograph imaging.
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: All participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of POCUS
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 minutesSecondary outcomes
1
Difference in diagnostic accuracy of POCUS in diagnosing a femoral neck or pertrochanteric fracture
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 minutes2
Difference in diagnostic accuracy of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS
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 minutes3
Difference in effusion measured in mm between the ipsilateral and contralateral hip
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 minutes4
Added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician
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)
Time frame
From enrollment to the end of POCUS, approximately 10 to 30 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: