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Can We 'hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures (CHEFF)

M

Medical Centre Leeuwarden

Status

Not yet enrolling

Conditions

Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)

Treatments

Diagnostic Test: POCUS of the hip

Study type

Interventional

Funder types

Other

Identifiers

NCT06765083
202400397

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

83 participants in 1 patient group

All participants
Experimental group
Description:
All patients enrolled in the study will undergo POCUS of the hip by the (resident) emergency physician, prior to radiograph imaging.
Treatment:
Diagnostic Test: POCUS of the hip

Trial contacts and locations

1

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Central trial contact

Svenja L Haak, MD; Lisanne M van der Lek, Drs

Data sourced from clinicaltrials.gov

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