Clinical trial NCT05003180: StUdy oN Burst Fractures (SunBurst)
Official title: SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Uppsala University Hospital
name: University Hospital, Umeå
name: University Hospital, Linkoeping
name: Skane University Hospital
name: Region Örebro County
name: Stockholm South General Hospital
name: Karolinska University Hospital
name: Oslo University Hospital
name: Haukeland University Hospital
name: Helse Stavanger HF
name: University Hospital, Akershus
name: Kalmar County Hospital
name: Ryhov County Hospital
name: Halmstad County Hospital
name: Centrallasarettet Västerås
name: St. Olavs Hospital
First posted: 2021-08-12
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
timeFrame: At 1 year after the fracture
Secondary outcomes:
measure: Group difference in Oswestry Disability Index (ODI) 3 to 4 months after the fracture
timeFrame: At 3 to 4 months after the fracture.
measure: Change in Oswestry Disability Index (ODI) from the time of the fracture to 3 to 4 months after the fracture
timeFrame: At the time of the fracture and 3 to 4 months after the fracture.
measure: Change in Oswestry Disability Index (ODI) from the time of the fracture to 1 year after the fracture
timeFrame: At the time of the fracture and 1 year after the fracture.
measure: Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3 to 4 months
timeFrame: At 3 to 4 months after the fracture.
measure: Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year
timeFrame: At 1 year after the fracture.
measure: Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 3 to 4 months after the fracture
timeFrame: At the time of the fracture and 3 to 4 months after the fracture.
measure: Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture
timeFrame: At the time of the fracture and 1 year after the fracture.
measure: Group difference in EQ-5D-5L at 3 to 4 months
timeFrame: At 3 to 4 months after the fracture.
measure: Group difference in EQ-5D-5L at 1 year
timeFrame: At 1 year after the fracture.
measure: Change in EQ-5D-5L from the time of the fracture to 3 to 4 months after the fracture
timeFrame: At the time of the fracture and 3 to 4 months after the fracture.
measure: Change in EQ-5D-5L from the time of the fracture to 1 year after the fracture
timeFrame: At the time of the fracture and 1 year after the fracture.
measure: Group difference in radiographic fracture pattern- standing radiograph
timeFrame: At 1 year after the fracture.
measure: Group difference in radiographic pattern- supine computed tomography at 1 year
timeFrame: At 1 year after the fracture.
measure: Group difference in radiographic pattern- supine computed tomography at 3 to 4 months
timeFrame: At 3 to 4 months after the fracture.
measure: Change in radiographic pattern- supine computed tomography - from the time of fracture to 3 to 4 months
timeFrame: From the time of fracture to 3 to 4 months after the fracture.
measure: Change in radiographic pattern- supine computed tomography - from 3 to 4 months to 1 year from the fracture
timeFrame: From 3 to 4 months to 1 year from the fracture after the fracture.
measure: Change in radiographic pattern- supine computed tomography - from the time of fracture to 1 year
timeFrame: From the time of fracture to 1 year after the fracture.
measure: Magnetic resonance imaging (MRI) at 1 year
timeFrame: At 1 year after the fracture.
measure: Imaging in correlation to patient reported outcome measures at 3 to 4 months from the fracture
timeFrame: At 3 to 4 months from the fracture
measure: Imaging in correlation to patient reported outcome measures at 1 year from the fracture
timeFrame: At 1 year after the fracture.
measure: Adverse events
timeFrame: 1 year after last subject recruitment
measure: Drug prescription/consumption
timeFrame: 1 year after last subject recruitment
measure: Sick leave
timeFrame: 1 year after last subject recruitment
measure: Individual cost from the time of fracture to 3 to 4 months
timeFrame: From the time of fracture to 3 to 4 months after the fracture.
measure: Individual cost from the time of fracture to 1 year
timeFrame: From the time of fracture to 1 year after the fracture.
measure: Incremental cost-effectiveness ratio
timeFrame: 1 year after last subject recruitment
measure: Mortality at 1 year
timeFrame: 1 year after last subject recruitment
measure: Mortality at 5 year
timeFrame: 5 years after last subject recruitment
measure: Mortality at 10 years
timeFrame: 10 years after last subject recruitment
measure: Oswestry Disability index (ODI) at 5 years
timeFrame: At 5 years after the fracture.
measure: Oswestry Disability index (ODI) at 10 years
timeFrame: At 10 years after the fracture.
measure: Short Musculoskeletal Function Assessment (SMFA) at 5 years
timeFrame: At 5 years after the fracture.
measure: Short Musculoskeletal Function Assessment (SMFA) at 10 years
timeFrame: At10 years after the fracture.
measure: EQ-5D-5L at 5 years
timeFrame: At 5 years after the fracture.
measure: EQ-5D-5L at 10 years
timeFrame: At10 years after the fracture.
measure: Sick leave at 5 years
timeFrame: At 5 years after the fracture.
measure: Sick leave at 10 years
timeFrame: At 10 years after the fracture.
measure: Social cost at 5 years
timeFrame: At 5 years after the fracture.
measure: Social cost at 10 years
timeFrame: At 10 years after the fracture.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Jönköping
country: Sweden
facility: Ryhov Hospital
city: Kalmar
country: Sweden
facility: Kalmar Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
city: Umeå
country: Sweden
facility: University Hospital of Umeå
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Central Hospital of Västerås
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Uppsala University, Uppsala University Hospital and Karolinska Institutet
name: Paul Gerdhem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Filip Dolatowski, MD, PhD
role: STUDY_DIRECTOR
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