StUdy oN Burst Fractures (SunBurst) (SunBurst)

• ClinicalTrials.gov Identifier: NCT05003180
• Recruitment Status: Recruiting
• First Posted: August 12, 2021
• Last Update Posted: January 26, 2023
• Sponsor: Karolinska Institutet
• Collaborators: Sahlgrenska University Hospital, Sweden; 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
• Information provided by (Responsible Party): Paul Gerdhem, Uppsala University

Study Description

Brief 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 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).

Condition or disease	Intervention/treatment	Phase
Thoracolumbar Burst Fracture	Procedure: Surgical stabilization	Not Applicable

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 with posterior fixation 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: December 31, 2025
• Estimated Study Completion Date: December 31, 2036

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Group difference in Oswestry Disability Index (ODI) 3 to 4 months after the fracture [ Time Frame: At 3 to 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.
2. Change in Oswestry Disability Index (ODI) from the time of the fracture to 3 to 4 months after the fracture [ Time Frame: At the time of the fracture and 3 to 4 months after the fracture. ]
   Change in ODI between groups.
3. Change in Oswestry Disability Index (ODI) from the time of the fracture to 1 year after the fracture [ Time Frame: At the time of the fracture and 1 year after the fracture. ]
   Change in ODI between groups.
4. Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3 to 4 months [ Time Frame: At 3 to 4 months after the fracture. ]
   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.
5. Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year [ Time Frame: At 1 year after the fracture. ]
   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.
6. Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 3 to 4 months after the fracture [ Time Frame: At the time of the fracture and 3 to 4 months after the fracture. ]
   Change in SMFA between groups.
7. Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture [ Time Frame: At the time of the fracture and 1 year after the fracture. ]
   Change in SMFA between groups.
8. Group difference in EQ-5D-5L at 3 to 4 months [ Time Frame: At 3 to 4 months after the fracture. ]
   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.
9. Group difference in EQ-5D-5L at 1 year [ Time Frame: At 1 year after the fracture. ]
   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.
10. Change in EQ-5D-5L from the time of the fracture to 3 to 4 months after the fracture [ Time Frame: At the time of the fracture and 3 to 4 months after the fracture. ]
    Change in EQ-5D-5L between groups.
11. Change in EQ-5D-5L from the time of the fracture to 1 year after the fracture [ Time Frame: At the time of the fracture and 1 year after the fracture. ]
    Change in EQ-5D-5L between groups.
12. Group difference in radiographic fracture pattern- standing radiograph [ Time Frame: At 1 year after the fracture. ]
    The patients will do a standing, whole spine radiograph. The degree of fracture compression, local and global kyphosis will be registered.
13. Group difference in radiographic pattern- supine computed tomography at 1 year [ Time Frame: At 1 year after the fracture. ]
    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.
14. Group difference in radiographic pattern- supine computed tomography at 3 to 4 months [ Time Frame: At 3 to 4 months after the fracture. ]
    The patients will do a computed tomography (CT) at 3 to 4 months after the fracture. The degree of fracture compression, local and global kyphosis and adjacent segment degeneration will be compared.
15. Change in radiographic pattern- supine computed tomography - from the time of fracture to 3 to 4 months [ Time Frame: From the time of fracture to 3 to 4 months after 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.
16. Change in radiographic pattern- supine computed tomography - from 3 to 4 months to 1 year from the fracture [ Time Frame: From 3 to 4 months to 1 year from the fracture after 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.
17. 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. ]
    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.
18. Magnetic resonance imaging (MRI) at 1 year [ Time Frame: At 1 year after the fracture. ]
    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.
19. Imaging in correlation to patient reported outcome measures at 3 to 4 months from the fracture [ Time Frame: At 3 to 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
20. Imaging in correlation to patient reported outcome measures at 1 year from the fracture [ Time Frame: At 1 year after 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.
21. Adverse events [ Time Frame: 1 year after last subject recruitment ]
    The subjects will be linked with The National Board of Health and Welfare National Patient Register by using their Swedish personal identity number (PIN). Data on the level of inpatient and outpatient healthcare, spinal surgery during follow up and adverse events (i.e., postoperative infections, thromboembolism, etc.) will be collected and compared between the study groups. In Norway similar data will be collected from the patient files and questionnaires.
22. Drug prescription/consumption [ Time Frame: 1 year after last subject recruitment ]
    Data on analgesics and antibiotics prescribed will be collected from The National Board of Health and Welfare Swedish Prescribed Drug Register. Collected prescriptions will be assessed as dichotomous data (collected/not collected) at different time intervals; 0 to 4 months and 4 months to 1 year. In Norway similar data will be collected from the patient files and questionnaires.
23. Sick leave [ Time Frame: 1 year after last subject recruitment ]
    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.
24. Individual cost from the time of fracture to 3 to 4 months [ Time Frame: From the time of fracture to 3 to 4 months after the fracture. ]
    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.
25. Individual cost from the time of fracture to 1 year [ Time Frame: From the time of fracture to 1 year after the fracture. ]
    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.
26. Incremental cost-effectiveness ratio [ Time Frame: 1 year after last subject recruitment ]
    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.
27. Mortality at 1 year [ Time Frame: 1 year after last subject recruitment ]
    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.
28. Mortality at 5 year [ Time Frame: 5 years after last subject recruitment ]
    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.
29. Mortality at 10 years [ Time Frame: 10 years after last subject recruitment ]
    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.
30. Oswestry Disability index (ODI) at 5 years [ Time Frame: At 5 years after the fracture. ]
    ODI are planned to be collected at 5 years.
31. Oswestry Disability index (ODI) at 10 years [ Time Frame: At 10 years after the fracture. ]
    ODI are planned to be collected at 10 years.
32. Short Musculoskeletal Function Assessment (SMFA) at 5 years [ Time Frame: At 5 years after the fracture. ]
    SMFA are planned to be collected after 5 years.
33. Short Musculoskeletal Function Assessment (SMFA) at 10 years [ Time Frame: At10 years after the fracture. ]
    SMFA are planned to be collected after 10 years.
34. EQ-5D-5L at 5 years [ Time Frame: At 5 years after the fracture. ]
    EQ-5D-5L are planned to be collected after 5 years.
35. EQ-5D-5L at 10 years [ Time Frame: At10 years after the fracture. ]
    EQ-5D-5L are planned to be collected after 10 years.
36. Sick leave at 5 years [ Time Frame: At 5 years after the fracture. ]
    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.
37. Sick leave at 10 years [ Time Frame: At 10 years after the fracture. ]
    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.
38. Social cost at 5 years [ Time Frame: At 5 years after the fracture. ]
    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.
39. Social cost at 10 years [ Time Frame: At 10 years after the fracture. ]
    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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Simon Blixt, MD; +46702518628; simon.blixt@ki.se

Contact: Maria Wikzén, RN; +46736994845; maria.wikzén@regionstockholm.se

Locations

Norway

Haukeland University Hospital; Recruiting

Bergen, Norway

Contact: Truls Rokne Hanestad truls.rokne.hanestad@helse-bergen.no

Akershus University Hospital; Recruiting

Oslo, Norway

Contact: Abdullah Cetinkaya abdullah.cetinkaya@ahus.no

Oslo University Hospital; Recruiting

Oslo, Norway

Contact: Filip Dolatowski +4745212525 fido@ous-hf.no

Stavanger University Hospital; Recruiting

Stavanger, Norway

Contact: Anne Kristin Reve anne.kristin.reve@sus.no

Sweden

Sahlgrenska University Hospital; Recruiting

Gothenburg, Sweden

Contact: Olof Westin, MD, PhD +46739521538 olof.westin@gmail.com

Halmstad Hospital; Recruiting

Halmstad, Sweden

Contact: Martin Kempny, MD martin.kempny@regionhalland.se

Ryhov Hospital; Recruiting

Jönköping, Sweden

Contact: Håkan Löfgren, MD, PhD hakan.lofgren@rjl.se

Kalmar Hospital; Recruiting

Kalmar, Sweden

Contact: Erik Vestberg, MD erik.vestberg@regionkalmar.se

Linköping University Hospital; Recruiting

Linköping, Sweden

Contact: Anders Olai, MD anders.olai@regionostergotland.se

Skåne University Hospital; Recruiting

Malmö, Sweden

Contact: Anders K Möller, MD, PhD anders.k.moller@skane.se

Contact: Ralph Hasserius, MD, PhD ralph.hasserius@skane.se

Karolinska University Hospital; Recruiting

Stockholm, Sweden, 14186

Contact: Simon Blixt, PhD Student +46702518628 simon.blixt@ki.se

Contact: Paul Gerdhem, MD, PhD +46736994409 paul.gerdhem@ki.se

Stockholm South General Hospital; Recruiting

Stockholm, Sweden

Contact: Ted Eneqvist, MD, PhD ted.eneqvist@regionstockholm.se

University Hospital of Umeå; Recruiting

Umeå, Sweden

Contact: Sebastian Mukka, MD, PhD +46730867111 sebastian.mukka@umu.se

Contact: Lukas Bobinski, MD, PhD lukas.bobinski@umu.se

Uppsala University Hospital; Recruiting

Uppsala, Sweden

Contact: Paul Gerdhem, MD, PhD +46736994409 paul.gerdhem@uu.se

Contact: Monica Sjöholm, Coordinator +46704250043

Central Hospital of Västerås; Recruiting

Västerås, Sweden

Contact: Olga Seikina, MD

Örebro University Hospital; Recruiting

Örebro, Sweden

Contact: Anders Joelson, MD, PhD anders.joelson@regionorebrolan.se

Contact: Freyr Gauti Sigmundsson, MD, PhD freyr.sigmundsson@regionorebrolan.se

Sponsors and Collaborators

Karolinska Institutet

Sahlgrenska University Hospital, Sweden

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

Investigators

• Principal Investigator: Paul Gerdhem, MD, PhD; Uppsala University, Uppsala University Hospital and Karolinska Institutet
• Study Director: Filip Dolatowski, MD, PhD; Oslo University Hospital

More Information

Additional Information:

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.) 

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.

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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.

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;(6):CD005079. doi: 10.1002/14651858.CD005079.pub3.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Paul Gerdhem, MD, PhD, Professor, Uppsala University
• ClinicalTrials.gov Identifier: NCT05003180
• Other Study ID Numbers: SB-PG-PF-OW-SM-2021-SunBurst; 2020-00493 ( Other Grant/Funding Number: The Swedish Research Council )
• First Posted: August 12, 2021
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD underlying published manuscripts will be accessible for other researchers.
• Supporting Materials: Study Protocol
• Time Frame: The study protocol will be submitted to a peer-reviewed journal. All source data including informed consents from each participating study center, a copy of the completed study database, original protocol with amendments and the final report will be stored at the Karolinska University Hospital for a minimum period of 10 years after termination of the trial.
• Access Criteria: The investigators in charge will be responsible for reviewing access requests. Crude data, randomization procedures and intervention details can be shared with other researchers upon request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Gerdhem, Uppsala University:

Thoracolumbar spine; Burst fractures; Thoracic or lumbar vertebrae; Register-based; Randomized controlled trial; Conservative treatment; Surgical treatment; Non-surgical treatment

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries