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Status unknownNCT02077855Updated May 31, 2017

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

An observational study in Pediatric Fractures, sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown at 1 site in Germany. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
Up to 5 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pediatric Fractures

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Keywords

  • Sensitivity and Sensitivity
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children with suspicion of Toddlers fractures.

Inclusion criteria

  1. Informed consent
  2. Suspicion of Toddlers fractures

Exclusion criteria

Exclusion Criteria:

  1. Major delay in treatment
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • Toddlers fractures
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What researchers measure

Primary outcomes

  1. Sonographic identification of "Toddler's" fractures

    Comparison of sensitivity and specitivity of sonography and x-ray

    Time frame: 3y

Secondary outcomes

  1. US does not cause more discomfort than x-ray

    Time frame: 3y

07

Study locations

1 of 1 sites recruiting
  • UKE Medical School
    Hamburg, Germany
    • Michael Boettcher, M.D. · Contact · michboettcher@gmail.com · +494088908180
    • Michael Boettcher, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02077855
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Dr. med. Michael Boettcher (PD Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Mar 4, 2014
Start date
Jan 2016
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
May 31, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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