Remodelling After Trampoline Fracture in Children

March 3, 2020 updated by: Peter Klimek
The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

86

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

  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
      • Bern, Switzerland, 3010
        • Universitätsspital Bern

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

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children between 2-5 years of life with the diagnosis of a trampoline fracture in the radiographs of the tibia in two views at the Kantonsspital Aarau, Universitätsspital Bern, Universitätskinderspital Zürich, UKBB Universitätsspital Basel, Kantonalspital Luzern.

Description

Inclusion Criteria:

  • trampoline fracture of the proximal lower leg

Exclusion Criteria:

  • proximal tibial fractures with unclear etiology

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anterior tilt angle of the tibia
Time Frame: one year after fracture
radiological measurement of the anterior tilt angle of the tibia (degree)
one year after fracture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia
Time Frame: one year after fracture
difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia (degree)
one year after fracture

Collaborators and Investigators

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

Sponsor

Peter Klimek

Collaborators

Medical Research Council Kantonsspital Aarau, Switzerland

Investigators

  • Principal Investigator: Peter Klimek, Dr. med, Kantonsspital Aarau

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 (Actual)

February 10, 2016

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-445; ex15Klimek

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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