NCT Number: NCT05003180
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–66 year
All sexes
Interventional
Not applicable
Oslo University Hospital, Oslo, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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 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.
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. 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.
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. The first item pain will be separately analysed as part of a sensitivity analysis of the primary outcome.
Time frame: At 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.
Time frame: At 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.
Time frame: At 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.
Time frame: At enrollment to 3-4 months after the fracture.
Change in ODI between groups.
Time frame: At enrollment to 1 year after the fracture.
Change in ODI between groups.
Time frame: At 3-4 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.
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.
Time frame: At enrollment to 3-4 months after the fracture.
Change in SMFA between groups.
Time frame: At enrollment to 1 year after the fracture.
Change in SMFA between groups.
Time frame: At 3-4 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.
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.
Time frame: At enrollment to 3-4 months after the fracture.
Change in EQ-5D-5L between groups.
Time frame: At enrollment to 1 year after the fracture.
Change in EQ-5D-5L between groups.
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.
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.
Time frame: At 3-4 months after the fracture.
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.
Time frame: From the time of fracture to 3-4 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.
Time frame: From 3-4 months after the 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.
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.
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.
Time frame: 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.
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.
Time frame: 1 year after last subject recruitment
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.
Time frame: 1 year after last subject recruitment
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.
Time frame: 1 year after inclusion
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.
Time frame: From the time of fracture to 3-4 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.
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.
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.
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.
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.
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.
Time frame: At 5 years after the fracture.
ODI are planned to be collected at 5 years.
Time frame: At 10 years after the fracture.
ODI are planned to be collected at 10 years.
Time frame: At 5 years after the fracture.
SMFA are planned to be collected after 5 years.
Time frame: At10 years after the fracture.
SMFA are planned to be collected after 10 years.
Time frame: At 5 years after the fracture.
EQ-5D-5L are planned to be collected after 5 years.
Time frame: At10 years after the fracture.
EQ-5D-5L are planned to be collected after 10 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.
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.
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.
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.
Uppsala University
Other
SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
Acronym: SunBurst
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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