StUdy oN Burst Fractures (SunBurst)

NCT05003180 | Active Not Recruiting

• 4 other identifiers: SB-PG-PF-OW-SM-2021-SunBurst2020-00493No grant numberRV-1010099, RV-1030408
• Study Type: interventional
• Target: 202
• Locations: 2 countries
• Sites: 17

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (44)

• Categories of Oswestry Disability Index (ODI) 1 year after the fracture

  At 1 year after the fracture

• Group difference in Oswestry Disability Index (ODI) 1 year after the fracture, adjusted.

  At 1 year after the fracture.

• Group difference in Oswestry Disability Index (ODI) first item (pain) 1 year after the fracture

  At 1 year after the fracture

• Group difference in Oswestry Disability Index (ODI) 3-4 months after the fracture

  At 3-4 months after the fracture.

• Categories of Oswestry Disability Index (ODI) 3-4 months after the fracture

  At 3-4 months after the fracture

Study Arms (2)

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.

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.

Interventions

Surgical stabilization PROCEDURE

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.

Surgical

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Sahlgrenska University Hospital: collaborator
• Uppsala University Hospital: collaborator
• University Hospital, Umeå: collaborator
• University Hospital, Linkoeping: collaborator
• Skane University Hospital: collaborator
• Region Örebro County: collaborator
• Stockholm South General Hospital: collaborator
• Karolinska University Hospital: collaborator
• Oslo University Hospital: collaborator
• Haukeland University Hospital: collaborator
• Helse Stavanger HF: collaborator
• University Hospital, Akershus: collaborator
• Kalmar County Hospital: collaborator
• Ryhov County Hospital: collaborator
• Halmstad County Hospital: collaborator
• Centrallasarettet Västerås: collaborator
• St. Olavs Hospital: collaborator

Study Sites (17)

Oslo University Hospital

Oslo, Oslo County, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Akershus University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Linköping, Sweden

Location

Skåne University Hospital

Malmo, Malmö, Sweden

Location

Stockholm South General Hospital

Stockholm, Stockholm County, Sweden

Location

University Hospital of Umeå

Umeå, Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Location

Halmstad Hospital

Halmstad, Sweden

Location

Ryhov Hospital

Jönköping, Sweden

Location

Kalmar Hospital

Kalmar, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Central Hospital of Västerås

Västerås, Sweden

Location

Related Publications (31)

• 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.

  PMID: 25593358 BACKGROUND

• 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.

  PMID: 25396259 BACKGROUND

• 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.

  PMID: 22057820 BACKGROUND

• 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.

  PMID: 25953527 BACKGROUND

• 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.

  PMID: 28816869 BACKGROUND

• 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.

  PMID: 17054237 BACKGROUND

• 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.

  PMID: 15690209 BACKGROUND

• 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.

  PMID: 17320622 BACKGROUND

• 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.

  PMID: 28815163 BACKGROUND

• 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.

  PMID: 23740669 BACKGROUND

• 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.

  PMID: 24981907 BACKGROUND

• 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.

  PMID: 31567716 BACKGROUND

• 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.

  PMID: 25174800 BACKGROUND

• Wennergren D, Moller M. Implementation of the Swedish Fracture Register. Unfallchirurg. 2018 Dec;121(12):949-955. doi: 10.1007/s00113-018-0538-z.

  PMID: 30178109 BACKGROUND

• 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.

  PMID: 32567472 BACKGROUND

• 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.

  PMID: 31964340 BACKGROUND

• 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.

  PMID: 23970107 BACKGROUND

• 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.

  PMID: 23508335 BACKGROUND

• 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.

  PMID: 25781411 BACKGROUND

• 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.

  PMID: 21131801 BACKGROUND

• 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.

  PMID: 30299485 BACKGROUND

• 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.

  PMID: 6450426 BACKGROUND

• 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.

  PMID: 21479777 BACKGROUND

• 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.

  PMID: 11074683 BACKGROUND

• 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.

  PMID: 19646379 BACKGROUND

• 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.

  PMID: 14763711 BACKGROUND

• 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.

  PMID: 32307663 BACKGROUND

• 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.

  PMID: 12592542 BACKGROUND

• 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.

  PMID: 18201937 BACKGROUND

• 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.

  PMID: 26656986 BACKGROUND

• 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.

  PMID: 35175357 DERIVED

Related 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 Officials

• Paul Gerdhem, MD, PhD

  Uppsala University, Uppsala University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Filip Dolatowski, MD, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2036
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD: Beginning after publication of the primary study results. Supporting information: Study protocol: is attached. Statistical analysis plan: Is attached
• 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.

Locations

NO (5); SE (12)