Value of Sonographic Diagnosis of Toddler's Fracture of the Tibia

Pediatric Fractures Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077855
• Other study ID #: PV3964
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2012
• Last updated: May 27, 2017
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: May 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

Description:

This fracture of the distal tibia occurs in 1 to 4 year-old-children. The child usually presents with an acute onset of limp or refusal to bear weight on one leg. Toddlers and young children may present with guarding, but may not have swelling or noticeable deformity.

Radiologic signs can be subtle too. In some cases initial radiographs is negative and fractures are diagnosed on follow-up studies by periosteal reaction.

However, timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. In children it is of particular value as it is comfortable and does not involve the use of ionizing radiation.

The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

1. Informed consent

2. Suspicion of Toddlers fractures

Exclusion Criteria:

1. Major delay in treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Pediatric Fractures

Locations

Country	Name	City	State
Germany	UKE Medical School	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sonographic identification of "Toddler's" fractures	Comparison of sensitivity and specitivity of sonography and x-ray	3y
Secondary	US does not cause more discomfort than x-ray		3y