NCT04028908

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 10, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.9 years

First QC Date

July 10, 2019

Last Update Submit

March 3, 2020

Conditions

Trampoline FractureTibial Fracture

Keywords

ventral tilting of the tibial plateauanterior tilt angleproximal tibia epiphyseal plate

Outcome Measures

Primary Outcomes (1)

  • anterior tilt angle of the tibia

    radiological measurement of the anterior tilt angle of the tibia (degree)

    one year after fracture

Secondary Outcomes (1)

  • difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia

    one year after fracture

Interventions

radiographs in two views of the tibiaDIAGNOSTIC_TEST

The anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden).

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • trampoline fracture of the proximal lower leg

You may not qualify if:

  • proximal tibial fractures with unclear etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Universitätsspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Peter Klimek, Dr. med

    Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 23, 2019

Study Start

February 10, 2016

Primary Completion

January 15, 2020

Study Completion

January 31, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

CH(2)