Thoracic FractureNCT03952182
Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
A study testing Spinal Orthosis (LSO, TLSO) and No orthosis in people with Thoracic Fracture and Lumbar Fracture, run by St. Louis University at 1 site in United States.
Trial summary
Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Fracture, Lumbar Fracture, Compression Fracture of Thoracic Vertebral Body
- What is being tested?
- Spinal Orthosis (LSO, TLSO) and No orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2020to 22 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care
Who cannot join
- neurological deficit, pregnant, incarcerated, non-English speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Hospital
St Louis, Missouri, 63110
About this study
Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.
Read the detailed description
Several tens of patient's per year come to the Emergency Department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. Currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. All braces are through the currently contracted orthotics company. As they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a Miami J collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. No only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. The patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. The braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. The investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.
- Conditions
- Thoracic Fracture, Lumbar Fracture, Compression Fracture of Thoracic Vertebral Body, Compression Fracture of Lumbar Spine, Burst Fracture of Thoracic Vertebra, Burst Fracture of Lumbar Vertebra
- Being tested
- Spinal Orthosis (LSO, TLSO), No orthosis
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Orthosis (LSO, TLSO)Other
spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture)
No orthosisOther
no orthotic given for spinal fracture. These patient's will be given a bending restriction
| Study group | Role | What they receive |
|---|---|---|
| Spinal Orthosis (LSO, TLSO, etc) | Active comparator | Patient's in this arm will be given an orthosis for the treatment of their injury (TLSO for thoracic or upper lumbar injury, LSO for lumbar injury) Receives: Other: Spinal Orthosis (LSO, TLSO) |
| No Spinal Orthosis | Experimental | the patient's in this arm will not be given an orthotic. They will be given a bending restriction and otherwise remain activities as tolerated. Receives: Other: No orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Primary outcome is the ODI which is a a self-completed questionnaire over ten topics regarding pain, lifting, ability to perform activities of daily living, ability to walk, sit, stand, one's sexual function, social life, sleep quality, and ability to travel. Each category has six different statements from which the patient can choose to best describe their current status. Each question is then scored on a scale from 0-5. Scores are summed and then doubled. The index is from 0-100 with zero being no disability and one hundred being maximally disabled.
Measured: 6 month post-injury
Secondary outcomes (4)
Visual analog scale (VAS)
VAS is a continuous scale represented as a horizontal line with vertical dashes numbered 0-10. Each number is given a pain intensity descriptor that ranges from "no pain" (score of 1) to "worst imaginable pain" (score of 10). The patient is asked to rate the pain they are currently experiencing on that scale from 1-10
Measured: Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
SF-12
Measured: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
PROMIS is a U.S. NIH initiative that is an item bank of self-administered questions to measure physical function. This includes functionality of one's upper extremities (dexterity), lower extremities (mobility), neck, back, as well as ability to perform activities of daily living. This assessment measures current function rather than function over a time period. Each question has five response options ranging in value from 1-5. The total raw score for the form is the sum of the values of the response to each question. The raw score (which can range from 10 (worst) to 50 (best) is then compared to a PROMIS specific conversion chart to the appropriate T-score. A T-score of roughly 50 is considered 'average' and 'slightly sicker than the general population'.
Measured: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Return to Work Status
Patient's will be asked if they currently work at time of injury and at each consecutive follow up appointment will be asked if they have returned to work
Measured: follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start5 Jan 2020
- Primary completion15 Mar 2020
- Study completion22 Mar 2022
Why it stopped: Recruitment and follow up concerns during Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Behrens, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952182
- Sponsor's protocol ID
- 29976
- Status last verified
- Mar 2022
- First submitted
- 13 May 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
- ClinicalTrials.gov ID
- NCT03952182
- Acronym / sponsor ID
- 29976
- Conditions
- Thoracic Fracture, Lumbar Fracture, Compression Fracture of Thoracic Vertebral Body, Compression Fracture of Lumbar Spine, Burst Fracture of Thoracic Vertebra, Burst Fracture of Lumbar Vertebra
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and follow up concerns during Covid-19 pandemic
- Enrolment
- 1 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.
Detailed description
Several tens of patient's per year come to the Emergency Department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. Currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. All braces are through the currently contracted orthotics company. As they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a Miami J collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. No only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. The patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. The braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. The investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Orthosis (LSO, TLSO, etc) | Active comparator | Other: Spinal Orthosis (LSO, TLSO)Patient's in this arm will be given an orthosis for the treatment of their injury (TLSO for thoracic or upper lumbar injury, LSO for lumbar injury) |
| No Spinal Orthosis | Experimental | Other: No orthosisthe patient's in this arm will not be given an orthotic. They will be given a bending restriction and otherwise remain activities as tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care
Key exclusion criteria (1 listed)
- neurological deficit, pregnant, incarcerated, non-English speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age
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 |
|---|---|---|
| Spinal Orthosis (LSO, TLSO)spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture) | Other | Spinal Orthosis (LSO, TLSO, etc) |
| No orthosisno orthotic given for spinal fracture. These patient's will be given a bending restriction | Other | No Spinal Orthosis |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 6 month post-injury
Primary outcome is the ODI which is a a self-completed questionnaire over ten topics regarding pain, lifting, ability to perform activities of daily living, ability to walk, sit, stand, one's sexual function, social life, sleep quality, and ability to travel. Each category has six different statements from which the patient can choose to best describe their current status. Each question is then scored on a scale from 0-5. Scores are summed and then doubled. The index is from 0-100 with zero being no disability and one hundred being maximally disabled.
4 secondary outcomes
Visual analog scale (VAS)
Time frame: Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
SF-12
Time frame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
Time frame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Return to Work Status
Time frame: follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Results and safety
The study was stopped early (reason given: Recruitment and follow up concerns during Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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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.
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 Spinal Orthosis (LSO, TLSO) and No orthosis in people with Thoracic Fracture and Lumbar Fracture, run by St. Louis University at 1 site in United States.
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: stopped early, as of the sponsor's last update on 24 Mar 2022. 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 United States. 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 was stopped early (reason given: Recruitment and follow up concerns during Covid-19 pandemic). Results are not available in the source record.
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?
Oswestry Disability Index (ODI) (time frame: 6 month post-injury). 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 24 Mar 2022.