Thoracolumbar Burst FractureNCT02827214
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
An observational study of Thoracolumbar Burst Fracture, run by AO Innovation Translation Center at 14 sites in 10 countries.
Trial summary
Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracolumbar Burst Fracture
- How many people
- 213 participants
- Where
- 14 sitesin 10 countries
- Study dates
- Oct 2016to 31 Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thoracolumbar burst fractures
Who may be able to join
- Skeletally mature, age 18 to 65 years old inclusive
- Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC injury (M1) from T10 to L2.
- Patients may have an associated B injury, but must have an A3 or A4.
- TLICS Score between 2-5 inclusive
- Acute fracture - diagnosis and treatment within 10 days of injury
- Ability to understand the content of the patient information / informed consent form
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- Willingness and ability to participate in the clinical investigation including imaging and FU procedures
- Investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated IRB/EC-approved written informed consent
Who cannot join
- Any neurological deficit associated with the fracture. Absence of neurological deficit will be determined with the International Standards for Neurological Classification of Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically intact/normal) of the patient.
- Spontaneous fractures due to pathologic processes or neoplasia
- Head injuries causing inability to cooperate during hospital admission
- Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
- Prior spinal surgeries in thoracic or lumbar spine
- Additional musculoskeletal, head or other injuries which would preclude rapid mobilization
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- Multiple trauma or Injury Severity Score (ISS) > 16
- Other co-morbidities precluding the patient to be considered as a surgical or non-surgical candidate, i.e. burns, dementia, BMI > 40, etc.
- Any severe systemic medical disease that would exclude the patient to be a potential candidate for surgery
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment.
- Pregnancy or women planning to conceive within the study period
Trial locations and contacts
14 sites in 10 countries.
14 sites in 10 countries
United States4 sites
SUNY Upstate
East Syracuse, New York, 13057
West Virginia University
Morgantown, West Virginia, 26506-9496
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of California, San Diego Medical Center
San Diego, California, 92093
Canada2 sites
Hopital l'Enfant-Jesus, CHU de Quebec
Québec, 1401
Vancouver General Hospital
Vancouver, V5z1M9
Australia1 site
Alfred Health operating through the Alfred hospital
Melbourne, 3004
About this study
Official title: Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.
Read the detailed description
208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC) injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study. Patients may have an associated B injury, but must have an A3 or A4. Patients will be monitored prospectively for patient reported, clinical and radiologic outcomes, over a period of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability Index (ODI), and employment information (indirect costs questionnaire) every second week until 6 months post-treatment. Diary will continue every second month until 2 years post-treatment. All interventions/examinations are considered as standard of care.
- Conditions
- Thoracolumbar Burst Fracture
- Keywords
- Thoracolumbar spine, Burst fractures, Conservative treatment, Surgical treatment, Thoracic or lumbar vertebrae
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 |
|---|---|---|
| Surgical treatment | Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail Approaches: * Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression * Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression * Posterior short or long fixation with posterolateral corpectomy and reconstruction * Anterior alone instrumentation * Combined Anterior Posterior (AP) instrumentation * Percutaneous posterior fixation combined with anterior instrumentation * Percutaneous posterior fixation with or without vertebroplasty | |
| Non-surgical treatment | Non-surgical treatment is defined as bed rest followed by immobilization with: * Custom-molded or prefabricated total body contact thoracolumbosacral orthosis (TLSO) * Thermoplastic removable brace * Jewett hyperextension braces * Anterior hyperextension brace (ASH) * Taylor-Knight brace * Plaster of Paris (POP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
ODI within the first year after surgical or non-surgical treatment using time to event analysis
Measured: 1 year
Secondary outcomes (9)
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
AOSpine PROST consists of 19 questions on aspects of functioning such as personal care, traveling, and emotional functioning after the accident causing the spinal injury. Each item has a 0-100 numeric rating scale, supported by smileys at both ends of the ruler. It is important to realize that 0 indicates a level at which the patient is non-functional and 100 indicates the level before the accident, no matter how well or poorly the patient functioned before the accident.
Measured: 2 years
Quality of life EQ5D-3L
The EuroQoL-5D (EQ-5D) is a standardized instrument that was designed for self-completion. It has five items (mobility, self-care, usual activities, pain / discomfort and anxiety / depression) with a three-point categorical response scale (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status will be assessed.
Measured: 2 years
Numeric Pain Rating Scale (NPRS)
The NPRS measures the subjective intensity of pain. The patient is asked to make a pain rating, corresponding to his/her experienced pain.
Measured: 2 years
Spine Adverse Events Severity System (SAVES)
The SAVES is a prospective adverse event (AE) recording instrument. The AEs are defined as any unexpected or undesirable events occurring as a result of spinal surgery, and a complication as a disease or disorder, which, as a consequence of a surgical procedure, that will negatively affect the outcome of a patient.
Measured: 2 years
overall satisfaction with the treatment
The overall satisfaction with treatment questionnaire contents one question regarding the satisfaction with the results of the recent treatment of the spine injury with a rating system from extremely satisfied (1) to not sure/no opinion (8)
Measured: 2 years
Non-surgical treatment failure rate
Failure rate of conservative treatment will be assessed during this study. Non-surgical treatment failure is defined as necessity of surgery after non-surgical treatment.
Measured: 2 years
Surgical treatment failure rate
Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
Measured: 2 years
indirect cost questionnaire
The indirect cost questionnaire assesses the personal situation of the patient at his workplace regarding to health, support, and their financial income statement
Measured: 2 years
Validation of AO TL Classification System aided by the analysis of CT scans
The participating clinics will upload the clinical data (de-identified X-rays, CT, MRI images) on a secure web-based platform. AOSpine Knowledge Forum Trauma Steering committee members, blinded to the diagnosis made in the study, will analyze the different images to validate the different TL fractures type A3 or A4 with or without PLC injury according to the new AOSpine TL Classification System.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracolumbar Burst 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Sponsor
- Investigators
- Marcel Dvorak, MD, Principal investigator, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827214
- Sponsor's protocol ID
- Spine_TL-A3-A4
- Status last verified
- Jan 2023
- First submitted
- 23 May 2016
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Canseco JA, Reinhold M, Dalton J, Dandurand C, Oner CF, Dvorak M, Wee Tee J, El-Sharkawi M, Vaccaro AR, Cezar Popescu E, Rajasekaran S, Benneker LM, Bransford RJ, Joaquim AF, Chhabra HS, Spiegl UJA, Hauri D, Schnake KJ, Bigdon SF, France JC, Paquet J, Allen RT, Lavelle W, Hirschfield M, Pneumaticos S, Schroeder GD. Acute thoracolumbar burst fractures (AO types A3/A4) with and without concomitant posterior ligamentous complex injury: treatment outcomes in surgically and nonsurgically managed patients. A multi-center prospective study. Eur Spine J. 2026 Jul;35(7):4420-4437. doi: 10.1007/s00586-025-09680-5. Epub 2026 Mar 19.
PubMed 41854908
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
- ClinicalTrials.gov ID
- NCT02827214
- Acronym / sponsor ID
- Spine_TL-A3-A4
- Conditions
- Thoracolumbar Burst Fracture
- Keywords
- Thoracolumbar spine, Burst fractures, Conservative treatment, Surgical treatment, Thoracic or lumbar vertebrae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jul 2016 (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.
Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.
Detailed description
208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC) injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study. Patients may have an associated B injury, but must have an A3 or A4. Patients will be monitored prospectively for patient reported, clinical and radiologic outcomes, over a period of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability Index (ODI), and employment information (indirect costs questionnaire) every second week until 6 months post-treatment. Diary will continue every second month until 2 years post-treatment. All interventions/examinations are considered as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | –Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail Approaches: * Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression * Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression * Posterior short or long fixation with posterolateral corpectomy and reconstruction * Anterior alone instrumentation * Combined Anterior Posterior (AP) instrumentation * Percutaneous posterior fixation combined with anterior instrumentation * Percutaneous posterior fixation with or without vertebroplasty |
| Non-surgical treatment | – | –Non-surgical treatment is defined as bed rest followed by immobilization with: * Custom-molded or prefabricated total body contact thoracolumbosacral orthosis (TLSO) * Thermoplastic removable brace * Jewett hyperextension braces * Anterior hyperextension brace (ASH) * Taylor-Knight brace * Plaster of Paris (POP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracolumbar burst fractures
Key inclusion criteria (9 listed)
- Skeletally mature, age 18 to 65 years old inclusive
- Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC injury (M1) from T10 to L2.
- Patients may have an associated B injury, but must have an A3 or A4.
- TLICS Score between 2-5 inclusive
- Acute fracture - diagnosis and treatment within 10 days of injury
Key exclusion criteria (13 listed)
- Any neurological deficit associated with the fracture. Absence of neurological deficit will be determined with the International Standards for Neurological Classification of Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically intact/normal) of the patient.
- Spontaneous fractures due to pathologic processes or neoplasia
- Head injuries causing inability to cooperate during hospital admission
- Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
- Prior spinal surgeries in thoracic or lumbar 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
Oswestry Disability Index (ODI)
Time frame: 1 year
ODI within the first year after surgical or non-surgical treatment using time to event analysis
9 secondary outcomes
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
Time frame: 2 years
Quality of life EQ5D-3L
Time frame: 2 years
Numeric Pain Rating Scale (NPRS)
Time frame: 2 years
Spine Adverse Events Severity System (SAVES)
Time frame: 2 years
overall satisfaction with the treatment
Time frame: 2 years
Non-surgical treatment failure rate
Time frame: 2 years
Surgical treatment failure rate
Time frame: 2 years
indirect cost questionnaire
Time frame: 2 years
Validation of AO TL Classification System aided by the analysis of CT scans
Time frame: 2 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 31 Jan 2023.
- Derived from this study: PubMed 41854908Canseco JA, Reinhold M, Dalton J, Dandurand C, Oner CF, Dvorak M, Wee Tee J, El-Sharkawi M, Vaccaro AR, Cezar Popescu E, Rajasekaran S, Benneker LM, Bransford RJ, Joaquim AF, Chhabra HS, Spiegl UJA, Hauri D, Schnake KJ, Bigdon SF, France JC, Paquet J, Allen RT, Lavelle W, Hirschfield M, Pneumaticos S, Schroeder GD. Acute thoracolumbar burst fractures (AO types A3/A4) with and without concomitant posterior ligamentous complex injury: treatment outcomes in surgically and nonsurgically managed patients. A multi-center prospective study. Eur Spine J. 2026 Jul;35(7):4420-4437. doi: 10.1007/s00586-025-09680-5. Epub 2026 Mar 19.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marcel Dvorak, MD principal investigator
Vancouver General Hospital
14 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracolumbar Burst Fracture, run by AO Innovation Translation Center at 14 sites in 10 countries.
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 9 inclusion and 13 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Australia, Egypt, Greece and 5 more countries. 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?
Oswestry Disability Index (ODI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827214, which also lists 1 linked publication.
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 31 Jan 2023.