Clinical trial NCT06765083: Can We 'hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures
Official title: Can We 'hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Keywords: femoral neck
pertrochanteric
hip
fracture
POCUS
ultrasound
diagnostic
Emergency Department
proximal femur
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* presenting to the ED with a painful hip after trauma, suspected of hip fracture as defined by the attending clinician

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Diagnostic accuracy of POCUS
timeFrame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Secondary outcomes:
measure: Difference in diagnostic accuracy of POCUS in diagnosing a femoral neck or pertrochanteric fracture
timeFrame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
measure: Difference in diagnostic accuracy of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS
timeFrame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
measure: Difference in effusion measured in mm between the ipsilateral and contralateral hip
timeFrame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
measure: Added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician
timeFrame: From enrollment to the end of POCUS, approximately 10 to 30 minutes
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
Study officials:
References:
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