Traumatic Burst Fractures of the Thoracic or Lumbar Spine.NCT02076607
Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment
An observational study of Traumatic Burst Fractures of the Thoracic or Lumbar Spine. and Normal Neurological Function, run by Hospital Ortopedico de Passo Fundo at 1 site in Brazil.
Trial summary
Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment. Read more about this study
- Who is it for?
- Ages 22 to 69 years
- Conditions the study is for
- Traumatic Burst Fractures of the Thoracic or Lumbar Spine., Normal Neurological Function
- What is being tested?
- Arthrodesis and Brace
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Jul 2013
- 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 22 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical treatment Group: 14 samples Conservative Treatment Group: 11 samples
Who may be able to join
- Patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the Service of the researcher, Orthopedic Hospital of Passo Fundo, with minimum follow-up of 24 months fracture.
Who cannot join
- Patients with neurological deficit or who have left before 24 months the follow-up.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Ortopedico de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010080
About this study
Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.
Read the detailed description
The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. Most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. The authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.However, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). This study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.
- Being tested
- Arthrodesis, Brace
- Keywords
- vertebra, column, lumbar, toracica, fracture, burst
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrodesisProcedure or surgery
Also called PLIF, TLIF
Posterior approach to toracolumbar spine fusion.
BraceDevice
Also called Jewett, Putti
Toracolumbar imobilization
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment | Eleven patients underwent conservative treatment with Brace. Receives: Device: Brace | |
| Surgical Treatment | Fourteen patients who underwent surgical treatment (arthrodesis). Receives: Procedure: Arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)
Retrospective review of medical records and imaging studies (radiographs and CT scans) of 30 patients without neurological deficit, with fractures of the thoracic and lumbar burst-type, in the archives of the Orthopedic Hospital of Passo Fundo, in the period between 2002 to 2011 submitted the clinical follow-up or post-operative periodical by the principal investigator of the study. The fractures, of the selected patients will be classified according to Magerl et al. (AO). Minimum follow-up is 24 months. It should be emphasized that all patients underwent at follow-up, the measurement of visual analog pain scale (VAS), the SF36 quality of life questionnaire, radiographic measurements of kyphosis, collapse and narrowing of the spinal canal. The clinical results obtained with conservative and surgical treatment will be compared and correlated with the morphological changes presented by the fractured vertebra.
Measured: Over Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Burst Fractures of the Thoracic or Lumbar Spine.Studies 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
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ortopedico de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego da Silva Collares, Hospital Ortopedico de Passo Fundo
- Investigators
- Diego S Collares, MD, Principal investigator, Hospital Ortopedico de Passo FundoRodrigo A Tisot, MD, Study director, Hospital Ortopedico de Passo FundoAndrius Berardi, MD, Principal investigator, Hospital Ortopedico de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076607
- Sponsor's protocol ID
- 314151
- Other IDs
- 314151
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment
- ClinicalTrials.gov ID
- NCT02076607
- Acronym / sponsor ID
- 314151
- Keywords
- vertebra, column, lumbar, toracica, fracture, burst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Ortopedico de Passo FundoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 Mar 2014 (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.
Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.
Detailed description
The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. Most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. The authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.However, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). This study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment | – | Device: BraceEleven patients underwent conservative treatment with Brace. |
| Surgical Treatment | – | Procedure: ArthrodesisFourteen patients who underwent surgical treatment (arthrodesis). |
Who may qualify
- Ages
- 22 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical treatment Group: 14 samples Conservative Treatment Group: 11 samples
Key inclusion criteria (1 listed)
- Patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the Service of the researcher, Orthopedic Hospital of Passo Fundo, with minimum follow-up of 24 months fracture.
Key exclusion criteria (1 listed)
- Patients with neurological deficit or who have left before 24 months the follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthrodesisAlso: PLIF, TLIFPosterior approach to toracolumbar spine fusion. | Procedure or surgery | Surgical Treatment |
| BraceAlso: Jewett, PuttiToracolumbar imobilization | Device | Conservative Treatment |
Primary outcome
Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)
Time frame: Over Two Years
Retrospective review of medical records and imaging studies (radiographs and CT scans) of 30 patients without neurological deficit, with fractures of the thoracic and lumbar burst-type, in the archives of the Orthopedic Hospital of Passo Fundo, in the period between 2002 to 2011 submitted the clinical follow-up or post-operative periodical by the principal investigator of the study. The fractures, of the selected patients will be classified according to Magerl et al. (AO). Minimum follow-up is 24 months. It should be emphasized that all patients underwent at follow-up, the measurement of visual analog pain scale (VAS), the SF36 quality of life questionnaire, radiographic measurements of kyphosis, collapse and narrowing of the spinal canal. The clinical results obtained with conservative and surgical treatment will be compared and correlated with the morphological changes presented by the fractured vertebra.
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 3 Mar 2014.
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.
Diego S Collares, MD principal investigator
Hospital Ortopedico de Passo Fundo
Rodrigo A Tisot, MD study director
Hospital Ortopedico de Passo Fundo
Andrius Berardi, MD principal investigator
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 Traumatic Burst Fractures of the Thoracic or Lumbar Spine. and Normal Neurological Function, run by Hospital Ortopedico 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 3 Mar 2014. 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?
Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary) (time frame: Over Two 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 3 Mar 2014.