NCT02514993

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

10.9 years

First QC Date

July 31, 2015

Last Update Submit

August 3, 2015

Conditions

Thoracic Spine FractureConcomitant Sternal Fracture

Keywords

Sternal fractureThoracic spine fractureThoracic cage injury

Outcome Measures

Primary Outcomes (1)

  • Survival

    Patient survival after polytraumatization

    1 year after trauma

Study Arms (2)

Study group

Inclusion criteria for the study were (a) sternal fracture and concomitant thoracic spine fracture, (b) Injury Severity scale (ISS) ≥ 16, (c) age under 50 years, (d) presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital.

Control group

The inclusion criteria for the control group included: (a) Thoracic spine fracture without concomitant sternal fracture, (b) ISS ≥ 16, (c) age under 50 years, (d) presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital.

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering a thoracic spine fracture and a concomitant sternal fracture

You may qualify if:

  • 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

You may not qualify if:

  • Missing consent
  • Incomplete patient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mario Morgenstern, M.D.

    Trauma Center Murnau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 4, 2015

Study Start

January 1, 2003

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

August 4, 2015

Record last verified: 2015-07