Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children

NCT04290247 | Completed

• 2 other identifiers: UKBB-2020/0012020-00032
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the sensitivity of Ultrasound for Diagnostic of Fractures of the upper extremity compared to conventional x-ray in Children 0-18.

Conditions

Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray

Keywords

Pediatric; Ultrasound; X-ray; Fracture; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Sensitivity of Ultrasound diagnostic compared to X-ray

  1 year

Secondary Outcomes (3)

• Pain level

  1 year

• Time

  1 year

• Displacement

  2 years

Study Arms (1)

Ultrasound + X-ray

EXPERIMENTAL

Ultrasound first then x-ray examination

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound imaging for fracture diagnosis before conventional X-ray

Ultrasound + X-ray

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients presenting to the emergency room of the UKBB with a history of acute trauma to the upper extremities and suspected fracture of a long bone
• Age 0-18 years

You may not qualify if:

• Patient needing immediate medical attention (triage score 1 or 2)
• Severely displaced or open fractures
• Patient with neurovascular compromise distally to the suspected fracture.
• Patient with imaging studies obtained prior to the emergency room visit
• Patient with prior fracture of the affected area
• Patient with known allergy to ultrasound gel.
• Patient with suspected 'battered child' diagnosis.
• Unavailability of a study investigator able to perform the ultrasound examination within a reasonable time frame (15 min; see also 3.2).

Sponsors & Collaborators

• University Children's Hospital Basel: lead

Study Sites (1)

University Childrens Hospital for both Basel cantons

Basel, Canton of Basel-City, 4056, Switzerland

Location

Related Publications (1)

• Troxler D, Sanchez C, de Trey T, Mayr J, Walther M. Non-Inferiority of Point-of-Care Ultrasound Compared to Radiography to Diagnose Upper Extremity Fractures in Children. Children (Basel). 2022 Sep 30;9(10):1496. doi: 10.3390/children9101496.

  PMID: 36291432 RESULT

MeSH Terms

Conditions

Fractures, Bone; Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Ultrasound before X-ray for all included patients.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: May 12, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)