Thoracic Spine FractureNCT02514993
The Unstable Thoracic Cage Injury
An observational study of Thoracic Spine Fracture and Concomitant Sternal Fracture, run by BG Unfallklinik Murnau.
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 Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Thoracic Spine Fracture, Concomitant Sternal Fracture
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering a thoracic spine fracture and a concomitant sternal fracture
Who may be able to join
- 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
Who cannot join
- Missing consent
- Incomplete patient data
About this study
Official title: The Unstable Thoracic Cage Injury: The Concomitant Sternal Fracture Indicates a Severe Thoracic Spine Fracture
- 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
Read the detailed 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.
- Keywords
- Sternal fracture, Thoracic spine fracture, Thoracic cage injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient survival after polytraumatization
Measured: 1 year after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJan 2003
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spine FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Unfallklinik Murnau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mario Morgenstern, BG Unfallklinik Murnau
- Investigators
- Mario Morgenstern, M.D., Principal investigator, Trauma Center Murnau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514993
- Sponsor's protocol ID
- 10-2004-2013
- Status last verified
- Jul 2015
- First submitted
- 31 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unstable Thoracic Cage Injury: The Concomitant Sternal Fracture Indicates a Severe Thoracic Spine Fracture
- ClinicalTrials.gov ID
- NCT02514993
- Acronym / sponsor ID
- 10-2004-2013
- Keywords
- Sternal fracture, Thoracic spine fracture, Thoracic cage injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- BG Unfallklinik MurnauUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering a thoracic spine fracture and a concomitant sternal fracture
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Missing consent
- Incomplete patient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 1 year after trauma
Patient survival after polytraumatization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Morgenstern, M.D. principal investigator
Trauma Center Murnau
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Spine Fracture and Concomitant Sternal Fracture, run by BG Unfallklinik Murnau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.