NCT02077855

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

July 9, 2012

Last Update Submit

May 27, 2017

Conditions

Pediatric Fractures

Keywords

Sensitivity and Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Sonographic identification of "Toddler's" fractures

    Comparison of sensitivity and specitivity of sonography and x-ray

    3y

Secondary Outcomes (1)

  • US does not cause more discomfort than x-ray

    3y

Study Arms (1)

Toddlers fractures

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with suspicion of Toddlers fractures.

You may qualify if:

  • Informed consent
  • Suspicion of Toddlers fractures

You may not qualify if:

  • \. Major delay in treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKE Medical School

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Michael Boettcher

Study Record Dates

First Submitted

July 9, 2012

First Posted

March 4, 2014

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

DE(1)