StUdy oN Burst Fractures (SunBurst) (SunBurst)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracolumbar Burst Fracture
• Intervention / Treatment: Procedure: Surgical stabilization

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 Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Oslo, Norway
    • Akershus University Hospital
  • Stavanger, Norway
    • Stavanger University Hospital
  • Trondheim, Norway
    • St. Olavs Hospital
  • Oslo County
    • Oslo, Oslo County, Norway
      • Oslo University Hospital
• Sweden
  • Halmstad, Sweden
    • Halmstad Hospital
  • Jönköping, Sweden
    • Ryhov Hospital
  • Kalmar, Sweden
    • Kalmar Hospital
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital
  • Västerås, Sweden
    • Central Hospital of Västerås
  • Örebro, Sweden
    • Orebro University Hospital
  • Gothenburg
    • Gothenburg, Gothenburg, Sweden
      • Sahlgrenska University Hospital
  • Linköping
    • Linköping, Linköping, Sweden
      • Linkoping University Hospital
  • Malmö
    • Malmo, Malmö, Sweden
      • Skane University Hospital
  • Stockholm County
    • Stockholm, Stockholm County, Sweden
      • Stockholm South General Hospital
  • Umeå
    • Umeå, Umeå, Sweden
      • University Hospital of Umeå
  • Uppsala County
    • Uppsala, Uppsala County, Sweden
      • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical; 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.	Procedure: Surgical stabilization; 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.
No Intervention: Non-surgical treatment; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 1 year after the fracture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 1 year 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.	At 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.	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.	At 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.	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.	At 1 year after 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.	At 1 year 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.	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.	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.	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.	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.	10 years after last subject recruitment
Oswestry Disability index (ODI) at 5 years	ODI are planned to be collected at 5 years.	At 5 years after the fracture.
Oswestry Disability index (ODI) at 10 years	ODI are planned to be collected at 10 years.	At 10 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 5 years	SMFA are planned to be collected after 5 years.	At 5 years after the fracture.
Short Musculoskeletal Function Assessment (SMFA) at 10 years	SMFA are planned to be collected after 10 years.	At10 years after the fracture.
EQ-5D-5L at 5 years	EQ-5D-5L are planned to be collected after 5 years.	At 5 years after the fracture.
EQ-5D-5L at 10 years	EQ-5D-5L are planned to be collected after 10 years.	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.	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.	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.	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.	At 10 years after the fracture.
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.	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.	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.	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.	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.	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.	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.	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.	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.	At 3-4 months 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.	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.	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.	At 3-4 months 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.	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.	At enrollment to 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.	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.	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.	From 3-4 months after the fracture to 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.	At 3-4 months from 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.	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.	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.	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.	From the time of fracture to 3-4 months after the fracture.

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Karolinska University Hospital; Oslo University Hospital; Helse Stavanger HF; Haukeland University Hospital; St. Olavs Hospital; University Hospital, Akershus; Halmstad County Hospital; University Hospital, Linkoeping; Skane University Hospital; University Hospital, Umeå; Region Örebro County; Uppsala University Hospital; Stockholm South General Hospital; Kalmar County Hospital; Centrallasarettet Västerås; Ryhov County Hospital; Sahlgrenska University Hospital
• Investigators: Principal Investigator: Paul Gerdhem, MD, PhD, Uppsala University, Uppsala University Hospital and Karolinska Institutet; Study Director: Filip Dolatowski, MD, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
• Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.
• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
• Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.
• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
• Vianin M. Psychometric properties and clinical usefulness of the Oswestry Disability Index. J Chiropr Med. 2008 Dec;7(4):161-3. doi: 10.1016/j.jcm.2008.07.001.
• Ponzer S, Skoog A, Bergstrom G. The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe). Acta Orthop Scand. 2003 Dec;74(6):756-63. doi: 10.1080/00016470310018324.
• James S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol. 2015 May;12(5):312-6. doi: 10.1038/nrcardio.2015.33. Epub 2015 Mar 17.
• 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.
• Schouten 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.
• Gnanenthiran 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.
• Vaccaro 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.
• Oner 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.
• Yi 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.
• van 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.
• Dai 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.
• Rometsch 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.
• Ghobrial 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.
• Wallace 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.
• Emilsson 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.
• Wennergren D, Moller M. Implementation of the Swedish Fracture Register. Unfallchirurg. 2018 Dec;121(12):949-955. doi: 10.1007/s00113-018-0538-z.
• Wolf 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.
• Wolf O, Sjoholm P, Hailer NP, Moller M, Mukka S. Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr. 2020 Jan 21;20(1):19. doi: 10.1186/s12877-020-1418-2.
• Vaccaro AR, Oner C, Kepler CK, Dvorak M, Schnake K, Bellabarba C, Reinhold M, Aarabi B, Kandziora F, Chapman J, Shanmuganathan R, Fehlings M, Vialle L; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013 Nov 1;38(23):2028-37. doi: 10.1097/BRS.0b013e3182a8a381.
• Reinhold M, Audige L, Schnake KJ, Bellabarba C, Dai LY, Oner FC. AO spine injury classification system: a revision proposal for the thoracic and lumbar spine. Eur Spine J. 2013 Oct;22(10):2184-201. doi: 10.1007/s00586-013-2738-0. Epub 2013 Mar 19.
• Ni WF, Huang YX, Chi YL, Xu HZ, Lin Y, Wang XY, Huang QS, Mao FM. Percutaneous pedicle screw fixation for neurologic intact thoracolumbar burst fractures. J Spinal Disord Tech. 2010 Dec;23(8):530-7. doi: 10.1097/BSD.0b013e3181c72d4c.
• Chi JH, Eichholz KM, Anderson PA, Arnold PM, Dailey AT, Dhall SS, Harrop JS, Hoh DJ, Qureshi S, Rabb CH, Raksin PB, Kaiser MG, O'Toole JE. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Evaluation and Treatment of Patients With Thoracolumbar Spine Trauma: Novel Surgical Strategies. Neurosurgery. 2019 Jan 1;84(1):E59-E62. doi: 10.1093/neuros/nyy364.
• Burstrom K, Teni FS, Gerdtham UG, Leidl R, Helgesson G, Rolfson O, Henriksson M. Experience-Based Swedish TTO and VAS Value Sets for EQ-5D-5L Health States. Pharmacoeconomics. 2020 Aug;38(8):839-856. doi: 10.1007/s40273-020-00905-7.
• Jonas WB, Crawford C, Colloca L, Kaptchuk TJ, Moseley B, Miller FG, Kriston L, Linde K, Meissner K. To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ Open. 2015 Dec 11;5(12):e009655. doi: 10.1136/bmjopen-2015-009655.
• Blixt S, Mukka S, Forsth P, Westin O, Gerdhem P; SunBurst study group. Study protocol: The SunBurst trial-a register-based, randomized controlled trial on thoracolumbar burst fractures. Acta Orthop. 2022 Jan 24;93:256-263. doi: 10.2340/17453674.2022.1614.
• Abudou 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.

Helpful Links

• Information on the National Board of Health and Welfare,The National Patient Register.
• Information on the National Board of Health and Welfare, The Swedish Prescribed Drug Register.
• Information in Swedish on the National Board of Health and Welfare, Cause of Death Register (Socialstyrelsen. Dödsorsaksregistret.)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2036

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Conservative treatment; Surgical treatment; Non-surgical treatment; Thoracolumbar spine; Burst fractures; Thoracic or lumbar vertebrae; Register-based
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: SB-PG-PF-OW-SM-2021-SunBurst; 2020-00493 (Other Grant/Funding Number: The Swedish Research Council); No grant number (Other Grant/Funding Number: The Swedish Society of Spinal Surgeons); RV-1010099, RV-1030408 (Other Grant/Funding Number: ALF medel Region Västerbotten)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing Time Frame

IPD:

Beginning after publication of the primary study results.

Supporting information:

Study protocol: is attached. Statistical analysis plan: Is attached

• IPD Sharing Access Criteria: Access to pseudonymized individual participant data will only be granted following approval by the Swedish ethical authority and completion of appropriate data sharing agreements. The investigators in charge will administer access in accordance with applicable data protection legislation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No