The Unstable Thoracic Cage Injury

Thoracic Spine Fracture Clinical Trial

Official title:

The Unstable Thoracic Cage Injury: The Concomitant Sternal Fracture Indicates a Severe Thoracic Spine Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514993
• Other study ID #: 10-2004-2013
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: August 3, 2015
• Start date: January 2003
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: BG Unfallklinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethik Kommission der Bayerischen Landesärztekammer: Germany
• Study type: Observational

Clinical Trial Summary

• Analysis of patient data and computed tomography scan of polytraumatized patients thoracic spine fractures

• A concomitant sternal fracture was identified an indicator for an unstable thoracic spine fracture

Description:

Previous studies stated, that sternal fractures can be regarded as an indicator for thoracic spine fractures and described the combined injury pattern of thoracic spine fracture and sternal fracture as "upper thoracic cage injury". But literature research is lacking data that in patients with a thoracic cage injury a highly unstable thoracic spine fracture can be expected.

In a large cohort of 130 patients with a thoracic spine fracture and concomitant sternal fracture the investigators analyzed the injury pattern and evaluated associated injuries, trauma mechanism, and clinical outcome.

The investigators could prove that in patients with a thoracic cage injury the concomitant sternal fracture may be regarded as an indicator for an unstable thoracic spine fracture, which requires surgical stabilization. Furthermore the analysis revealed that even a highly rotationally unstable type C fracture has to be expected, if sternal and thoracic spine fractures are located in the same segment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Sternal fracture and concomitant thoracic spine fracture

• Injury Severity Scale = 16

• Age under 50 years

• Presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital

Exclusion Criteria:

• Missing consent

• Incomplete patient data

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Concomitant Sternal Fracture
• Fractures, Bone
• Spinal Fractures
• Thoracic Spine Fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BG Unfallklinik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Patient survival after polytraumatization	1 year after trauma	No