Burst Thoracic Spine FracturesNCT01544933
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures
An observational study of Burst Thoracic Spine Fractures, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial summary
The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures. Read more about this study
- Who is it for?
- Ages 17 to 79 years
- Conditions the study is for
- Burst Thoracic Spine Fractures
- How many people
- 2 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Sep 2011
- 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 17 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with burst fractures of the thoracic spine treated by the Hospital Ortopedico de Passo Fundo
Who may be able to join
- burst fractures in thoracic spine
Who cannot join
- fractures that were not burst fractures in thoracic spine
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.
Read the detailed description
To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing
- Conditions
- Burst Thoracic Spine Fractures
- Keywords
- spinal fractures, Thoracic vertebrae, spinal canal, kyphosis
- Medical subject headings
- Spinal Fractures, Kyphosis
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 |
|---|---|---|
| burst fractures in vertebrae with true ribs | between T1 and T10 | |
| burst fractures in vertebrae with floating ribs | between T11 and T12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual kyphosis
measurement of residual kyphosis by x-ray
Measured: 3 years
Secondary outcomes (1)
vertebral canal narrowing
vertebral canal narrowing in CT
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burst Thoracic Spine FracturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Arnold Tisot, Universidade de Passo Fundo
- Investigators
- Rodrigo A Tisot, Dr, Study director, Hospital Ortopedico de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544933
- Sponsor's protocol ID
- rtisot01
- Status last verified
- Aug 2011
- First submitted
- 22 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures
- ClinicalTrials.gov ID
- NCT01544933
- Acronym / sponsor ID
- rtisot01
- Conditions
- Burst Thoracic Spine Fractures
- Keywords
- spinal fractures, Thoracic vertebrae, spinal canal, kyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Mar 2012 (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.
The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.
Detailed description
To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| burst fractures in vertebrae with true ribs | – | –between T1 and T10 |
| burst fractures in vertebrae with floating ribs | – | –between T11 and T12 |
Who may qualify
- Ages
- 17 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with burst fractures of the thoracic spine treated by the Hospital Ortopedico de Passo Fundo
Key inclusion criteria (1 listed)
- burst fractures in thoracic spine
Key exclusion criteria (1 listed)
- fractures that were not burst fractures in thoracic spine
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
residual kyphosis
Time frame: 3 years
measurement of residual kyphosis by x-ray
1 secondary outcome
vertebral canal narrowing
Time frame: 3 years
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 6 Mar 2012.
Related trials for Burst Thoracic Spine Fractures
Active, not recruiting
StUdy oN Burst Fractures (SunBurst)
Thoracolumbar Burst Fracture
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.
Rodrigo A Tisot, Dr study director
Hospital Ortopedico de Passo Fundo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burst Thoracic Spine Fractures, run by Universidade de Passo Fundo at 1 site in Brazil.
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 1 inclusion and 1 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
residual kyphosis (time frame: 3 years). 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 6 Mar 2012.