Thoracolumbar Burst FractureSunBurstNCT05003180
StUdy oN Burst Fractures (SunBurst)
A study testing Surgical stabilization in people with Thoracolumbar Burst Fracture, run by Uppsala University at 17 sites in 2 countries.
Trial summary
Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Thoracolumbar Burst Fracture
- What is being tested?
- Surgical stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 1 Sep 2021to 31 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification
- Aged 18-66 years
- Informed consent
- Acute injury with diagnosis and treatment within 2 weeks
- May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment
- May have a single nerve root injury
Who cannot join
- Unable to consent, no consent given or not informed
- Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury
- Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI
- Patients with ankylosing spinal disorders spanning the fracture area
- Prior spinal surgeries within the fractured area
- Open vertebral fracture
Show all 9Show fewer
- Additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care
- Patients not deemed suitable due to severe co-morbidities. (E.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.)
- Patients already included in the study cannot be randomized again if they get an additional spine fracture
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Sweden12 sites
Sahlgrenska University Hospital
Gothenburg, Gothenburg
Halmstad Hospital
Halmstad
Ryhov Hospital
Jönköping
Kalmar Hospital
Kalmar
Linköping University Hospital
Linköping, Linköping
Skåne University Hospital
Malmö, Malmö
Örebro University Hospital
Örebro
Stockholm South General Hospital
Stockholm, Stockholm County
Karolinska University Hospital
Stockholm, 14186
University Hospital of Umeå
Umeå, Umeå
Uppsala University Hospital
Uppsala, Uppsala County
Central Hospital of Västerås
Västerås
Norway5 sites
Haukeland University Hospital
Bergen
Oslo University Hospital
Oslo, Oslo
Akershus University Hospital
Oslo
Stavanger University Hospital
Stavanger
St. Olavs Hospital
Trondheim
About this study
Official title: SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a randomized controlled trial (RCT).
Read the detailed description
The study is an international, multicenter, randomized controlled trial. 202 patients with a single level TL burst fracture will be enrolled in the study. They will be randomized 1:1 to either surgery or non-surgical treatment. The study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. In non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. The subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. Data will be collected from questionnaires, patient files or national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.
- Conditions
- Thoracolumbar Burst Fracture
- Being tested
- Surgical stabilization
- Keywords
- Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical stabilizationProcedure or surgery
The surgical stabilization can be either open or minimally invasive. The recommended procedure is posterior fixation with pedicle screws and rods. Both short and long segment fixation are allowed in the study. It is up to the treating surgeon to decide on fusion or decompression. If feasible, pedicle screws are inserted in the fractured vertebra.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Active comparator | Surgical stabilization. Brace treatment will not be used postoperative. Early ambulation after surgery is encouraged. Surgery is to be performed within 2 weeks from the injury. The choice of supplier and brand of implants are based on the preference of each participating center.
Physiotherapy and other measures of rehabilitation are prescribed on an individual basis. Receives: Procedure: Surgical stabilization |
| Non-surgical treatment | No intervention | No surgical stabilization is performed. Early ambulation after treatment randomization is encouraged. Brace treatment is not required, but a standard three-point hyperextension brace may be offered up to 3 months for pain relief. The choice of supplier and brand of brace are based on the preference of each participating center. The brace will only be used upon mobilization. Brace use will be estimated by the patient at the 3-4 months follow-up. Physiotherapy and other measures of rehabilitation are prescribed on an individual basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
Measured: At 1 year after the fracture
Secondary outcomes (46)
Categories of Oswestry Disability Index (ODI) 1 year after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life and can be summed to an ODI 0-100 score. Participants will be dichotomised based on their ODI score (0-20 vs. 21-100). We will compare the proportions between groups. This is a secondary analysis of the primary outcome.
Measured: At 1 year after the fracture
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture, adjusted.
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life. The between-group difference in ODI at 1 year will be compared using linear regression adjusting for age, sex and fracture type (A3 vs A4). This will be part of a sensitivity analysis of the primary outcome.
Measured: At 1 year after the fracture.
Group difference in Oswestry Disability Index (ODI) first item (pain) 1 year after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life. The first item pain will be separately analysed as part of a sensitivity analysis of the primary outcome.
Measured: At 1 year after the fracture
Group difference in Oswestry Disability Index (ODI) 3-4 months after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
Measured: At 3-4 months after the fracture.
Categories of Oswestry Disability Index (ODI) 3-4 months after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life and can be summed to an ODI 0-100 score. Participants will be dichotomised based on their ODI score (0-20 vs. 21-100). We will compare the proportions between groups.
Measured: At 3-4 months after the fracture
Group difference in Oswestry Disability Index (ODI) first item (pain) 3-4 months after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
Measured: At 3-4 months after the fracture
Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 3-4 months after the fracture
Change in ODI between groups.
Measured: At enrollment to 3-4 months after the fracture.
Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 1 year after the fracture
Change in ODI between groups.
Measured: At enrollment to 1 year after the fracture.
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3-4 months
SMFA is a patient-reported outcome measure for a broad range of musculoskeletal disorders consisting of a total of 46 questions. 34 questions measure the patient's dysfunction and 12 questions measure how bothered the patients are by their symptoms.
Measured: At 3-4 months after the fracture.
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year
SMFA is a patient-reported outcome measure for a broad range of musculoskeletal disorders consisting of a total of 46 questions. 34 questions measure the patient's dysfunction and 12 questions measure how bothered the patients are by their symptoms.
Measured: At 1 year after the fracture.
Change in Short Musculoskeletal Function Assessment (SMFA) from baseline (prior injury) to 3-4 months after the fracture
Change in SMFA between groups.
Measured: At enrollment to 3-4 months after the fracture.
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture
Change in SMFA between groups.
Measured: At enrollment to 1 year after the fracture.
Group difference in EQ-5D-5L at 3-4 months
EQ-5D-5L is a standardized quality of life instrument developed by the EuroQol group. It consists of 5 dimensions measuring mobility, personal care, usual activities, pain/discomfort and anxiety/depression with 5 levels for each dimension (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). It also has a visual analog scale (EQ VAS) from 0 (worst possible health) to 100 (best possible health) to measure how the subjects consider their own health.
Measured: At 3-4 months after the fracture.
Group difference in EQ-5D-5L at 1 year
EQ-5D-5L is a standardized quality of life instrument developed by the EuroQol group. It consists of 5 dimensions measuring mobility, personal care, usual activities, pain/discomfort and anxiety/depression with 5 levels for each dimension (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). It also has a visual analog scale (EQ VAS) from 0 (worst possible health) to 100 (best possible health) to measure how the subjects consider their own health.
Measured: At 1 year after the fracture.
Change in EQ-5D-5L from baseline (prior injury) to 3-4 months after the fracture
Change in EQ-5D-5L between groups.
Measured: At enrollment to 3-4 months after the fracture.
Change in EQ-5D-5L from baseline (prior injury) to 1 year after the fracture
Change in EQ-5D-5L between groups.
Measured: At enrollment to 1 year after the fracture.
Group difference in radiographic fracture pattern- standing radiograph
The patients will do a standing, whole spine radiograph. The degree of fracture compression, local and global kyphosis will be registered.
Measured: At 1 year after the fracture.
Group difference in radiographic pattern- supine computed tomography at 1 year
The patients will do a computed tomography (CT) 1 year after the fracture. The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be compared.
Measured: At 1 year after the fracture.
Group difference in radiographic pattern- supine computed tomography at 3-4 months
The patients will do a computed tomography (CT) at 3-4 months after the fracture. The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be compared.
Measured: At 3-4 months after the fracture.
Change in radiographic pattern- supine computed tomography - from the time of fracture to 3-4 months
The patients will do a computed tomography (CT). The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be registered. Group comparisons of radiological changes will be performed.
Measured: From the time of fracture to 3-4 months after the fracture.
Change in radiographic pattern- supine computed tomography - from 3-4 months to 1 year from the fracture
The patients will do a computed tomography (CT). The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be registered. Group comparisons of radiological changes will be performed.
Measured: From 3-4 months after the fracture to 1 year after the fracture.
Change in radiographic pattern- supine computed tomography - from the time of fracture to 1 year
The patients will do a computed tomography (CT). The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be registered. Group comparisons of radiological changes will be performed.
Measured: From the time of fracture to 1 year after the fracture.
Magnetic resonance imaging (MRI) at 1 year
The patients will do a magnetic resonance imaging (MRI). The degree of fracture compression, local and global kyphosis, adjacent segment degeneration and extent of any soft tissue injuries will be registered. Group comparisons of MRI changes will be performed.
Measured: At 1 year after the fracture.
Imaging in correlation to patient reported outcome measures at 3-4 months from the fracture
The degree of fracture compression, local and global kyphosis, adjacent segment degeneration and extent of any soft tissue injuries registered on computed tomography (CT) will be compared to patient reported outcome measures at 3 to 4 months.
Measured: At 3-4 months from the fracture.
Imaging in correlation to patient reported outcome measures at 1 year from the fracture
The degree of fracture compression, local and global kyphosis, adjacent segment degeneration and extent of any soft tissue injuries registered on X-ray, CT and MRI will be compared to patient reported outcome measures at 1 year.
Measured: At 1 year after the fracture.
Adverse events
Adverse events will be collected from medical records and patient-reported questionnaires, the National Patient Register administered by the National Board of Health and Welfare and the Swedish Fracture register in Sweden. For participants treated in Norway, corresponding data will be collected from medical records and patient-reported questionnaires. The number of adverse events will be compared between the study groups.
Measured: 1 year after last subject recruitment
Drug prescription/consumption
Data on prescribed analgesics and antibiotics will be obtained from the Swedish Prescribed Drug Register administered by the National Board of Health and Welfare. Prescription data will be analyzed as dichotomous variables (yes/no) for predefined time intervals: 0-4 months and 4-12 months following injury.
For participants treated in Norway, corresponding information will be collected through review of medical records and patient-reported questionnaires.
Measured: 1 year after last subject recruitment
Sick leave
Data from the Swedish Social Insurance Agency / Statistics Sweden will be collected to compare sick leave and loss of income due to the fracture. Data will be stratified based on the presence or absence of sick leave before the fracture event. Data on total time on sick leave as well as the diagnosis used for sick leave will be collected. In Norway similar data will be collected from the patient files and questionnaires.
Measured: 1 year after inclusion
Individual cost from the time of fracture to 3-4 months
The number of outpatient and telephone contacts (physician, nurse, physiotherapist) and salary losses the fracture and treatment have resulted in will be collected from patient files and official health registries and compared between the groups.
Measured: From the time of fracture to 3-4 months after the fracture.
Individual cost from the time of fracture to 1 year
The number of outpatient and telephone contacts (physician, nurse, physiotherapist) and salary losses the fracture and treatment have resulted in will be collected from patient files and official health registries and compared between the groups.
Measured: From the time of fracture to 1 year after the fracture.
Incremental cost-effectiveness ratio
Quality-adjusted life years (QALYs) will be calculated for each group as measured by EQ-5D-5L. Combining cost and QALY yields the incremental cost-effectiveness ratio (ICER) of the surgical intervention as compared to non-surgical care.
Measured: 1 year after last subject recruitment
Mortality at 1 year
Mortality, including the cause of death, will be collected from the National Board of Health and Welfare Cause of Death Register. In Norway data will be collected from official registries.
Measured: 1 year after last subject recruitment
Mortality at 5 year
Mortality, including the cause of death, will be collected from the National Board of Health and Welfare Cause of Death Register. In Norway data will be collected from official registries.
Measured: 5 years after last subject recruitment
Mortality at 10 years
Mortality, including the cause of death, will be collected from the National Board of Health and Welfare Cause of Death Register. In Norway data will be collected from official registries.
Measured: 10 years after last subject recruitment
Oswestry Disability index (ODI) at 5 years
ODI are planned to be collected at 5 years.
Measured: At 5 years after the fracture.
Oswestry Disability index (ODI) at 10 years
ODI are planned to be collected at 10 years.
Measured: At 10 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 5 years
SMFA are planned to be collected after 5 years.
Measured: At 5 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 10 years
SMFA are planned to be collected after 10 years.
Measured: At10 years after the fracture.
EQ-5D-5L at 5 years
EQ-5D-5L are planned to be collected after 5 years.
Measured: At 5 years after the fracture.
EQ-5D-5L at 10 years
EQ-5D-5L are planned to be collected after 10 years.
Measured: At10 years after the fracture.
Sick leave at 5 years
Long-term data on sick leave are to be collected from the Social Insurance Agency at 5 years to compare difference in long-term sick leave between study groups. In Norway similar data will be collected from patient files and questionnaires.
Measured: At 5 years after the fracture.
Sick leave at 10 years
Long-term data on sick leave are to be collected from the Social Insurance Agency at 10 years to compare difference in long-term sick leave between study groups. In Norway similar data will be collected from patient files and questionnaires.
Measured: At 10 years after the fracture.
Social cost at 5 years
Analysis of the long-term social cost will be calculated for each treatment by collecting data on cost from sick leave from the Social Insurance Agency, estimated cost from health care visits collected from the National Patient Register and estimated cost on pharmaceutical prescriptions from the Prescribed Drug Register at 5 years. In Norway similar data will be collected from patient files and questionnaires.
Measured: At 5 years after the fracture.
Social cost at 10 years
Analysis of the long-term social cost will be calculated for each treatment by collecting data on cost from sick leave from the Social Insurance Agency, estimated cost from health care visits collected from the National Patient Register and estimated cost on pharmaceutical prescriptions from the Prescribed Drug Register at 10 years. In Norway similar data will be collected from patient files and questionnaires.
Measured: At 10 years after the fracture.
AO-PROST at 5 years
The questionnaire AO-PROST (AO-Patient Reported Outcome Spine Trauma) answered 5 years after the fracture
Measured: At 5 years after the fracture
AO-PROST at 10 years
The questionnaire AO-PROST (AO-Patient Reported Outcome Spine Trauma) answered 10 years after the fracture
Measured: At 10 years after the fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2026
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. Subjects are identified through spine services at hospitals throughout Sweden and Norway. The subjects are screened for eligibility. Subjects are randomized in a 1:1 ratio to surgical or non-surgical treatment.
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University Hospital, University Hospital, Umeå, University Hospital, Linkoeping, Skane University Hospital, Region Örebro County, Stockholm South General Hospital, Karolinska University Hospital, Oslo University Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital, Akershus, Kalmar County Hospital, Ryhov County Hospital, Halmstad County Hospital, Centrallasarettet Västerås, St. Olavs Hospital
- Responsible party
- Principal investigator, Paul Gerdhem, Uppsala University
- Investigators
- Paul Gerdhem, MD, PhD, Principal investigator, Uppsala University, Uppsala University Hospital and Karolinska InstitutetFilip Dolatowski, MD, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003180
- Sponsor's protocol ID
- SB-PG-PF-OW-SM-2021-SunBurst
- Other IDs
- 2020-00493, No grant number, RV-1010099, RV-1030408
- Acronym
- SunBurst
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying the results reported in publications will be shared in a pseudonymized form with external researchers only if required approvals are in place. Data can only be made available subject to approval by the Swedish ethical authority, appropriate data sharing agreements, and compliance with applicable data protection legislation.
Publications
Rajasekaran S, Kanna RM, Shetty AP. Management of thoracolumbar spine trauma: An overview. Indian J Orthop. 2015 Jan-Feb;49(1):72-82. doi: 10.4103/0019-5413.143914.
PubMed 25593358Schouten R, Lewkonia P, Noonan VK, Dvorak MF, Fisher CG. Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients. J Neurosurg Spine. 2015 Jan;22(1):101-11. doi: 10.3171/2014.9.SPINE13849.
PubMed 25396259Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5.
PubMed 22057820Vaccaro AR, Schroeder GD, Kepler CK, Cumhur Oner F, Vialle LR, Kandziora F, Koerner JD, Kurd MF, Reinhold M, Schnake KJ, Chapman J, Aarabi B, Fehlings MG, Dvorak MF. The surgical algorithm for the AOSpine thoracolumbar spine injury classification system. Eur Spine J. 2016 Apr;25(4):1087-94. doi: 10.1007/s00586-015-3982-2. Epub 2015 May 8.
PubMed 25953527Oner C, Rajasekaran S, Chapman JR, Fehlings MG, Vaccaro AR, Schroeder GD, Sadiqi S, Harrop J. Spine Trauma-What Are the Current Controversies? J Orthop Trauma. 2017 Sep;31 Suppl 4:S1-S6. doi: 10.1097/BOT.0000000000000950.
PubMed 28816869Yi L, Jingping B, Gele J, Baoleri X, Taixiang W. Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005079. doi: 10.1002/14651858.CD005079.pub2.
PubMed 17054237van der Roer N, de Lange ES, Bakker FC, de Vet HC, van Tulder MW. Management of traumatic thoracolumbar fractures: a systematic review of the literature. Eur Spine J. 2005 Aug;14(6):527-34. doi: 10.1007/s00586-004-0847-5. Epub 2005 Feb 3.
PubMed 15690209Dai LY, Jiang SD, Wang XY, Jiang LS. A review of the management of thoracolumbar burst fractures. Surg Neurol. 2007 Mar;67(3):221-31; discussion 231. doi: 10.1016/j.surneu.2006.08.081.
PubMed 17320622Rometsch E, Spruit M, Hartl R, McGuire RA, Gallo-Kopf BS, Kalampoki V, Kandziora F. Does Operative or Nonoperative Treatment Achieve Better Results in A3 and A4 Spinal Fractures Without Neurological Deficit?: Systematic Literature Review With Meta-Analysis. Global Spine J. 2017 Jun;7(4):350-372. doi: 10.1177/2192568217699202. Epub 2017 Jul 7.
PubMed 28815163Abudou M, Chen X, Kong X, Wu T. Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD005079. doi: 10.1002/14651858.CD005079.pub3.
PubMed 23740669Ghobrial GM, Maulucci CM, Maltenfort M, Dalyai RT, Vaccaro AR, Fehlings MG, Street J, Arnold PM, Harrop JS. Operative and nonoperative adverse events in the management of traumatic fractures of the thoracolumbar spine: a systematic review. Neurosurg Focus. 2014;37(1):E8. doi: 10.3171/2014.4.FOCUS1467.
PubMed 24981907Wallace N, McHugh M, Patel R, Aleem IS. Effects of Bracing on Clinical and Radiographic Outcomes Following Thoracolumbar Burst Fractures in Neurologically Intact Patients: A Meta-Analysis of Randomized Controlled Trials. JBJS Rev. 2019 Sep;7(9):e9. doi: 10.2106/JBJS.RVW.19.00006.
PubMed 31567716Emilsson L, Lindahl B, Koster M, Lambe M, Ludvigsson JF. Review of 103 Swedish Healthcare Quality Registries. J Intern Med. 2015 Jan;277(1):94-136. doi: 10.1111/joim.12303. Epub 2014 Sep 27.
PubMed 25174800Wennergren D, Moller M. Implementation of the Swedish Fracture Register. Unfallchirurg. 2018 Dec;121(12):949-955. doi: 10.1007/s00113-018-0538-z.
PubMed 30178109Wolf O, Mukka S, Notini M, Moller M, Hailer NP; DUALITY GROUP. Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop. 2020 Oct;91(5):506-513. doi: 10.1080/17453674.2020.1780059. Epub 2020 Jun 22.
PubMed 32567472
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
- ClinicalTrials.gov ID
- NCT05003180
- Acronym / sponsor ID
- SunBurst / SB-PG-PF-OW-SM-2021-SunBurst
- Conditions
- Thoracolumbar Burst Fracture
- Keywords
- Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University Hospital, University Hospital, Umeå, University Hospital, Linkoeping, Skane University Hospital, Region Örebro County, Stockholm South General Hospital, Karolinska University Hospital, Oslo University Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital, Akershus, Kalmar County Hospital, Ryhov County Hospital, Halmstad County Hospital, Centrallasarettet Västerås, St. Olavs Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 12 Aug 2021 (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.
Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a randomized controlled trial (RCT).
Detailed description
The study is an international, multicenter, randomized controlled trial. 202 patients with a single level TL burst fracture will be enrolled in the study. They will be randomized 1:1 to either surgery or non-surgical treatment. The study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. In non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. The subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. Data will be collected from questionnaires, patient files or national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Subjects are identified through spine services at hospitals throughout Sweden and Norway. The subjects are screened for eligibility. Subjects are randomized in a 1:1 ratio to surgical or non-surgical treatment.
| Arm | Type | Receives |
|---|---|---|
| Surgical | Active comparator | Procedure: Surgical stabilizationSurgical stabilization. Brace treatment will not be used postoperative. Early ambulation after surgery is encouraged. Surgery is to be performed within 2 weeks from the injury. The choice of supplier and brand of implants are based on the preference of each participating center. Physiotherapy and other measures of rehabilitation are prescribed on an individual basis. |
| Non-surgical treatment | No intervention | –No surgical stabilization is performed. Early ambulation after treatment randomization is encouraged. Brace treatment is not required, but a standard three-point hyperextension brace may be offered up to 3 months for pain relief. The choice of supplier and brand of brace are based on the preference of each participating center. The brace will only be used upon mobilization. Brace use will be estimated by the patient at the 3-4 months follow-up. Physiotherapy and other measures of rehabilitation are prescribed on an individual basis. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification
- Aged 18-66 years
- Informed consent
- Acute injury with diagnosis and treatment within 2 weeks
- May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment
Key exclusion criteria (9 listed)
- Unable to consent, no consent given or not informed
- Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury
- Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI
- Patients with ankylosing spinal disorders spanning the fracture area
- Prior spinal surgeries within the fractured area
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 |
|---|---|---|
| Surgical stabilizationThe surgical stabilization can be either open or minimally invasive. The recommended procedure is posterior fixation with pedicle screws and rods. Both short and long segment fixation are allowed in the study. It is up to the treating surgeon to decide on fusion or decompression. If feasible, pedicle screws are inserted in the fractured vertebra. | Procedure or surgery | Surgical |
Primary outcome
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
Time frame: At 1 year after the fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
46 secondary outcomes
Categories of Oswestry Disability Index (ODI) 1 year after the fracture
Time frame: At 1 year after the fracture
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture, adjusted.
Time frame: At 1 year after the fracture.
Group difference in Oswestry Disability Index (ODI) first item (pain) 1 year after the fracture
Time frame: At 1 year after the fracture
Group difference in Oswestry Disability Index (ODI) 3-4 months after the fracture
Time frame: At 3-4 months after the fracture.
Categories of Oswestry Disability Index (ODI) 3-4 months after the fracture
Time frame: At 3-4 months after the fracture
Group difference in Oswestry Disability Index (ODI) first item (pain) 3-4 months after the fracture
Time frame: At 3-4 months after the fracture
Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 3-4 months after the fracture
Time frame: At enrollment to 3-4 months after the fracture.
Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 1 year after the fracture
Time frame: At enrollment to 1 year after the fracture.
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3-4 months
Time frame: At 3-4 months after the fracture.
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year
Time frame: At 1 year after the fracture.
Change in Short Musculoskeletal Function Assessment (SMFA) from baseline (prior injury) to 3-4 months after the fracture
Time frame: At enrollment to 3-4 months after the fracture.
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture
Time frame: At enrollment to 1 year after the fracture.
Group difference in EQ-5D-5L at 3-4 months
Time frame: At 3-4 months after the fracture.
Group difference in EQ-5D-5L at 1 year
Time frame: At 1 year after the fracture.
Change in EQ-5D-5L from baseline (prior injury) to 3-4 months after the fracture
Time frame: At enrollment to 3-4 months after the fracture.
Change in EQ-5D-5L from baseline (prior injury) to 1 year after the fracture
Time frame: At enrollment to 1 year after the fracture.
Group difference in radiographic fracture pattern- standing radiograph
Time frame: At 1 year after the fracture.
Group difference in radiographic pattern- supine computed tomography at 1 year
Time frame: At 1 year after the fracture.
Group difference in radiographic pattern- supine computed tomography at 3-4 months
Time frame: At 3-4 months after the fracture.
Change in radiographic pattern- supine computed tomography - from the time of fracture to 3-4 months
Time frame: From the time of fracture to 3-4 months after the fracture.
Change in radiographic pattern- supine computed tomography - from 3-4 months to 1 year from the fracture
Time frame: From 3-4 months after the fracture to 1 year after the fracture.
Change in radiographic pattern- supine computed tomography - from the time of fracture to 1 year
Time frame: From the time of fracture to 1 year after the fracture.
Magnetic resonance imaging (MRI) at 1 year
Time frame: At 1 year after the fracture.
Imaging in correlation to patient reported outcome measures at 3-4 months from the fracture
Time frame: At 3-4 months from the fracture.
Imaging in correlation to patient reported outcome measures at 1 year from the fracture
Time frame: At 1 year after the fracture.
Adverse events
Time frame: 1 year after last subject recruitment
Drug prescription/consumption
Time frame: 1 year after last subject recruitment
Sick leave
Time frame: 1 year after inclusion
Individual cost from the time of fracture to 3-4 months
Time frame: From the time of fracture to 3-4 months after the fracture.
Individual cost from the time of fracture to 1 year
Time frame: From the time of fracture to 1 year after the fracture.
Incremental cost-effectiveness ratio
Time frame: 1 year after last subject recruitment
Mortality at 1 year
Time frame: 1 year after last subject recruitment
Mortality at 5 year
Time frame: 5 years after last subject recruitment
Mortality at 10 years
Time frame: 10 years after last subject recruitment
Oswestry Disability index (ODI) at 5 years
Time frame: At 5 years after the fracture.
Oswestry Disability index (ODI) at 10 years
Time frame: At 10 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 5 years
Time frame: At 5 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 10 years
Time frame: At10 years after the fracture.
EQ-5D-5L at 5 years
Time frame: At 5 years after the fracture.
EQ-5D-5L at 10 years
Time frame: At10 years after the fracture.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 25593358Rajasekaran S, Kanna RM, Shetty AP. Management of thoracolumbar spine trauma: An overview. Indian J Orthop. 2015 Jan-Feb;49(1):72-82. doi: 10.4103/0019-5413.143914.
- Background: PubMed 25396259Schouten R, Lewkonia P, Noonan VK, Dvorak MF, Fisher CG. Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients. J Neurosurg Spine. 2015 Jan;22(1):101-11. doi: 10.3171/2014.9.SPINE13849.
- Background: PubMed 22057820Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5.
- Background: PubMed 25953527Vaccaro AR, Schroeder GD, Kepler CK, Cumhur Oner F, Vialle LR, Kandziora F, Koerner JD, Kurd MF, Reinhold M, Schnake KJ, Chapman J, Aarabi B, Fehlings MG, Dvorak MF. The surgical algorithm for the AOSpine thoracolumbar spine injury classification system. Eur Spine J. 2016 Apr;25(4):1087-94. doi: 10.1007/s00586-015-3982-2. Epub 2015 May 8.
- Background: PubMed 28816869Oner C, Rajasekaran S, Chapman JR, Fehlings MG, Vaccaro AR, Schroeder GD, Sadiqi S, Harrop J. Spine Trauma-What Are the Current Controversies? J Orthop Trauma. 2017 Sep;31 Suppl 4:S1-S6. doi: 10.1097/BOT.0000000000000950.
- Background: PubMed 17054237Yi L, Jingping B, Gele J, Baoleri X, Taixiang W. Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005079. doi: 10.1002/14651858.CD005079.pub2.
- Background: PubMed 15690209van der Roer N, de Lange ES, Bakker FC, de Vet HC, van Tulder MW. Management of traumatic thoracolumbar fractures: a systematic review of the literature. Eur Spine J. 2005 Aug;14(6):527-34. doi: 10.1007/s00586-004-0847-5. Epub 2005 Feb 3.
- Background: PubMed 17320622Dai LY, Jiang SD, Wang XY, Jiang LS. A review of the management of thoracolumbar burst fractures. Surg Neurol. 2007 Mar;67(3):221-31; discussion 231. doi: 10.1016/j.surneu.2006.08.081.
- Background: PubMed 28815163Rometsch E, Spruit M, Hartl R, McGuire RA, Gallo-Kopf BS, Kalampoki V, Kandziora F. Does Operative or Nonoperative Treatment Achieve Better Results in A3 and A4 Spinal Fractures Without Neurological Deficit?: Systematic Literature Review With Meta-Analysis. Global Spine J. 2017 Jun;7(4):350-372. doi: 10.1177/2192568217699202. Epub 2017 Jul 7.
- Background: PubMed 23740669Abudou M, Chen X, Kong X, Wu T. Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD005079. doi: 10.1002/14651858.CD005079.pub3.
- Background: PubMed 24981907Ghobrial GM, Maulucci CM, Maltenfort M, Dalyai RT, Vaccaro AR, Fehlings MG, Street J, Arnold PM, Harrop JS. Operative and nonoperative adverse events in the management of traumatic fractures of the thoracolumbar spine: a systematic review. Neurosurg Focus. 2014;37(1):E8. doi: 10.3171/2014.4.FOCUS1467.
- Background: PubMed 31567716Wallace N, McHugh M, Patel R, Aleem IS. Effects of Bracing on Clinical and Radiographic Outcomes Following Thoracolumbar Burst Fractures in Neurologically Intact Patients: A Meta-Analysis of Randomized Controlled Trials. JBJS Rev. 2019 Sep;7(9):e9. doi: 10.2106/JBJS.RVW.19.00006.
- Information on the National Board of Health and Welfare,The National Patient Register.Link provided by the sponsor.
- Information on the National Board of Health and Welfare, The Swedish Prescribed Drug Register.Link provided by the sponsor.
- Information in Swedish on the National Board of Health and Welfare, Cause of Death Register (Socialstyrelsen. Dödsorsaksregistret.)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD underlying the results reported in publications will be shared in a pseudonymized form with external researchers only if required approvals are in place. Data can only be made available subject to approval by the Swedish ethical authority, appropriate data sharing agreements, and compliance with applicable data protection legislation.
Related trials for Thoracolumbar Burst Fracture
Not yet recruitingObservational study
Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy
Thoracolumbar Burst Fractures
Recruiting
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
SPINAL Fracture, Burst Fracture
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.
Paul Gerdhem, MD, PhD principal investigator
Uppsala University, Uppsala University Hospital and Karolinska Institutet
Filip Dolatowski, MD, PhD study director
Oslo University Hospital
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical stabilization in people with Thoracolumbar Burst Fracture, run by Uppsala University at 17 sites in 2 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden, Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture. (time frame: At 1 year after the fracture). 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 NCT05003180, which also lists 31 linked publications.
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 28 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.