Thoracolumbar Burst Fractures Without Neurologic DeficitNCT01741168
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
A study testing TLSO and No Orthosis in people with Thoracolumbar Burst Fractures Without Neurologic Deficit, run by The London Spine Centre at 1 site in Canada.
Trial summary
Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Thoracolumbar Burst Fractures Without Neurologic Deficit
- What is being tested?
- TLSO and No Orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Sep 2011
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AO A3 burst fracture between T10 and L3 with associated kyphotic deformity <35 degrees
- neurologically intact or isolated nerve root deficit
- age 16-60 years
- enrollment within 3 days of injury
Who cannot join
- neurological deficit
- can not comply with brace wearing (pregnancy/body mass index >40)
- mobilized with or without a brace prior to recruitment
- suffered a pathologic or open fracture
- alcohol or drug abusers
- had previous injury or surgery to the thoracolumbar region
- unable to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.
Read the detailed description
The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.
- Being tested
- TLSO, No Orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLSOOther
Also called TLSO Aspen Medical Products, Irvine, CA, USA
Patients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist.
No OrthosisOther
Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TLSO | Active comparator | TLSO brace 8-10 weeks Receives: Other: TLSO |
| No Orthosis | Experimental | No Orthosis Receives: Other: No Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire
The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.
Measured: 3 months post fracture
Secondary outcomes (4)
SF-36 physical component summary score
Measured: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
SF-36 mental component summary score
Measured: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
VAS pain score
Measured: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Satisfaction with Treatment
Overall satisfaction with treatment was assessed on a seven point scale, using the sentence, "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture?" This is a recommended tool for assessing global satisfaction.
Measured: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJun 2005
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracolumbar Burst Fractures Without Neurologic DeficitStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- The London Spine Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741168
- Sponsor's protocol ID
- 11421
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
- ClinicalTrials.gov ID
- NCT01741168
- Acronym / sponsor ID
- 11421
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- The London Spine CentreUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Dec 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.
Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.
Detailed description
The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLSO | Active comparator | Other: TLSOTLSO brace 8-10 weeks |
| No Orthosis | Experimental | Other: No OrthosisNo Orthosis |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- AO A3 burst fracture between T10 and L3 with associated kyphotic deformity <35 degrees
- neurologically intact or isolated nerve root deficit
- age 16-60 years
- enrollment within 3 days of injury
Key exclusion criteria (7 listed)
- neurological deficit
- can not comply with brace wearing (pregnancy/body mass index >40)
- mobilized with or without a brace prior to recruitment
- suffered a pathologic or open fracture
- alcohol or drug abusers
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 |
|---|---|---|
| TLSOAlso: TLSO Aspen Medical Products, Irvine, CA, USAPatients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist. | Other | TLSO |
| No OrthosisPatients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks. | Other | No Orthosis |
Primary outcome
Roland Morris Disability Questionnaire
Time frame: 3 months post fracture
The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.
4 secondary outcomes
SF-36 physical component summary score
Time frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
SF-36 mental component summary score
Time frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
VAS pain score
Time frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Satisfaction with Treatment
Time frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 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 4 Dec 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLSO and No Orthosis in people with Thoracolumbar Burst Fractures Without Neurologic Deficit, run by The London Spine Centre at 1 site in Canada.
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 7 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 Dec 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 Canada. 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?
Roland Morris Disability Questionnaire (time frame: 3 months post fracture). 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 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.