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

Not Applicable

Not yet recruiting

• Conditions: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)

• Registration Number: NCT06765083
• Lead Sponsor: Medical Centre Leeuwarden

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.

Study Timeline

• Study First Submitted: 2024-12-03
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 83

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of POCUS	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).

Secondary Outcome Measures

Name	Time	Method
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 (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in diagnosing a femoral neck or pertrochanteric fracture
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 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
Difference in effusion measured in mm between the ipsilateral and contralateral hip	From enrollment to the end of POCUS, approximately 10 to 30 minutes	Difference in effusion measured in mm between the ipsilateral and contralateral hip
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	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)

Trial Locations

Locations (1)

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands