Remodelling After Trampoline Fracture in Children

Tibial Fracture Clinical Trial

Official title:

Remodelling After Trampoline Fracture in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028908
• Other study ID #: 2015-445; ex15Klimek
• Status: Completed
• Start date: February 10, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 31, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• trampoline fracture of the proximal lower leg

Exclusion Criteria:

• proximal tibial fractures with unclear etiology

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures
• Trampoline Fracture

Intervention

Diagnostic Test:
• radiographs in two views of the tibia
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).

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Universitätsspital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Peter Klimek	Medical Research Council Kantonsspital Aarau, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anterior tilt angle of the tibia	radiological measurement of the anterior tilt angle of the tibia (degree)	one year after fracture
Secondary	difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia	difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia (degree)	one year after fracture