Burst FractureNCT01979198
Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes
An observational study of Burst Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Burst Fracture
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Mar 2013
- How long will I take part?
- 10 Years
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients suffered from burst fracture of the thoracolumbar and lumbar spine
Who may be able to join
- neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
- incomplete neurological deficit with a canal compromise less than 50%;
- complete neurological deficit;
- multilevel spinal injury or multiple trauma.
Who cannot join
- progression of the neurological deficit;
- a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Analysis of Discs and Vertebral Body Height at Fractured and Adjacent Levels
The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.
- Conditions
- Burst Fracture
- Keywords
- burst fracture, kyphotic angle, surgical outcome
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 |
|---|---|---|
| fusion group | close reduction with posterior short-segment transpedicular screw fixation with posterior fusion | |
| non-fusion group | close reduction with posterior short-segment transpedicular screw fixation without posterior fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: postoperative 6 weeks
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: postoperative 12 weeks
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: postoperative 6 months
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: postoperative 12 months
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: postoperative 24 months
Radiologic outcomes
- Injured vertebral body height
- Kyphotic angle
- Regional segmental motion
Measured: up to postoperative 161 months
Secondary outcomes (2)
Functional outcomes
- Greenough Low Back Outcome Scale
- Visual Analogue Scale (VAS) for back pain
- Neurologic status: Frankel grading system
Measured: postoperative 24 months
Functional outcomes
- Greenough Low Back Outcome Scale
- Visual Analogue Scale (VAS) for back pain
- Neurologic status: Frankel grading system
Measured: up to postoperative 161 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burst FractureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Shih-Tien Wang, MD, Principal investigator, Department of Orthopedics and Traumatology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979198
- Sponsor's protocol ID
- 2012-03-030BC
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Analysis of Discs and Vertebral Body Height at Fractured and Adjacent Levels
- ClinicalTrials.gov ID
- NCT01979198
- Acronym / sponsor ID
- 2012-03-030BC
- Conditions
- Burst Fracture
- Keywords
- burst fracture, kyphotic angle, surgical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Nov 2013 (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 surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fusion group | – | –close reduction with posterior short-segment transpedicular screw fixation with posterior fusion |
| non-fusion group | – | –close reduction with posterior short-segment transpedicular screw fixation without posterior fusion |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients suffered from burst fracture of the thoracolumbar and lumbar spine
Key inclusion criteria (4 listed)
- neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
- incomplete neurological deficit with a canal compromise less than 50%;
- complete neurological deficit;
- multilevel spinal injury or multiple trauma.
Key exclusion criteria (2 listed)
- progression of the neurological deficit;
- a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.
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
Radiologic outcomes
Time frame: postoperative 6 weeks
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
Radiologic outcomes
Time frame: postoperative 12 weeks
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
Radiologic outcomes
Time frame: postoperative 6 months
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
Radiologic outcomes
Time frame: postoperative 12 months
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
Radiologic outcomes
Time frame: postoperative 24 months
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
Radiologic outcomes
Time frame: up to postoperative 161 months
* Injured vertebral body height * Kyphotic angle * Regional segmental motion
2 secondary outcomes
Functional outcomes
Time frame: postoperative 24 months
Functional outcomes
Time frame: up to postoperative 161 months
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 8 Nov 2013.
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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.
Shih-Tien Wang, MD principal investigator
Department of Orthopedics and Traumatology, Taipei Veterans General Hospital
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 Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 8 Nov 2013. 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 Taiwan. 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?
Radiologic outcomes (time frame: postoperative 6 weeks). The study lists 6 primary outcomes in all. 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 8 Nov 2013.