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

May 27, 2017 updated by: Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • UKE Medical School
        • Contact:
        • Principal Investigator:
          • Michael Boettcher, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with suspicion of Toddlers fractures.

Description

Inclusion Criteria:

  1. Informed consent
  2. Suspicion of Toddlers fractures

Exclusion Criteria:

1. Major delay in treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Toddlers fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sonographic identification of "Toddler's" fractures
Time Frame: 3y
Comparison of sensitivity and specitivity of sonography and x-ray
3y

Secondary Outcome Measures

Outcome Measure
Time Frame
US does not cause more discomfort than x-ray
Time Frame: 3y
3y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV3964

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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