Back to resultsStUdy oN Burst Fractures (SunBurst) (SunBurst)
Primary Purpose
Thoracolumbar Burst Fracture
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Surgical stabilization
Sponsored by
About this trial
This is an interventional treatment trial for Thoracolumbar Burst Fracture focused on measuring Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical 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
Sites / Locations
- Haukeland University HospitalRecruiting
- Akershus University HospitalRecruiting
- Oslo University HospitalRecruiting
- Stavanger University HospitalRecruiting
- St. Olavs Hospital
- Sahlgrenska University HospitalRecruiting
- Halmstad HospitalRecruiting
- Ryhov HospitalRecruiting
- Kalmar HospitalRecruiting
- Linköping University HospitalRecruiting
- Skåne University HospitalRecruiting
- Karolinska University HospitalRecruiting
- Stockholm South General HospitalRecruiting
- University Hospital of UmeåRecruiting
- Uppsala University HospitalRecruiting
- Central Hospital of VästeråsRecruiting
- Örebro University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Surgical
Non-surgical treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Group difference in Oswestry Disability Index (ODI) 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.
Change in Oswestry Disability Index (ODI) from the time of the fracture to 3 to 4 months after the fracture
Change in ODI between groups.
Change in Oswestry Disability Index (ODI) from the time of the fracture to 1 year after the fracture
Change in ODI between groups.
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3 to 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.
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.
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 3 to 4 months after the fracture
Change in SMFA between groups.
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture
Change in SMFA between groups.
Group difference in EQ-5D-5L at 3 to 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.
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.
Change in EQ-5D-5L from the time of the fracture to 3 to 4 months after the fracture
Change in EQ-5D-5L between groups.
Change in EQ-5D-5L from the time of the fracture to 1 year after the fracture
Change in EQ-5D-5L between groups.
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.
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.
Group difference in radiographic pattern- supine computed tomography at 3 to 4 months
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.
Change in radiographic pattern- supine computed tomography - from the time of fracture to 3 to 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.
Change in radiographic pattern- supine computed tomography - from 3 to 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.
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.
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.
Imaging in correlation to patient reported outcome measures 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
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.
Adverse events
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.
Drug prescription/consumption
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.
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.
Individual cost from the time of fracture to 3 to 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.
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.
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.
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.
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.
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.
Oswestry Disability index (ODI) at 5 years
ODI are planned to be collected at 5 years.
Oswestry Disability index (ODI) at 10 years
ODI are planned to be collected at 10 years.
Short Musculoskeletal Function Assessment (SMFA) at 5 years
SMFA are planned to be collected after 5 years.
Short Musculoskeletal Function Assessment (SMFA) at 10 years
SMFA are planned to be collected after 10 years.
EQ-5D-5L at 5 years
EQ-5D-5L are planned to be collected after 5 years.
EQ-5D-5L at 10 years
EQ-5D-5L are planned to be collected after 10 years.
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.
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.
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.
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.
Full Information
NCT ID
NCT05003180
First Posted
June 20, 2021
Last Updated
October 13, 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, St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05003180
Brief Title
StUdy oN Burst Fractures (SunBurst)
Acronym
SunBurst
Official Title
SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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, St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracolumbar Burst Fracture
Keywords
Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-surgical treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical stabilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
Description
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
Secondary Outcome Measure Information:
Title
Group difference in Oswestry Disability Index (ODI) 3 to 4 months after the fracture
Description
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 to 4 months after the fracture.
Title
Change in Oswestry Disability Index (ODI) from the time of the fracture to 3 to 4 months after the fracture
Description
Change in ODI between groups.
Time Frame
At the time of the fracture and 3 to 4 months after the fracture.
Title
Change in Oswestry Disability Index (ODI) from the time of the fracture to 1 year after the fracture
Description
Change in ODI between groups.
Time Frame
At the time of the fracture and 1 year after the fracture.
Title
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3 to 4 months
Description
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 3 to 4 months after the fracture.
Title
Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year
Description
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.
Title
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 3 to 4 months after the fracture
Description
Change in SMFA between groups.
Time Frame
At the time of the fracture and 3 to 4 months after the fracture.
Title
Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture
Description
Change in SMFA between groups.
Time Frame
At the time of the fracture and 1 year after the fracture.
Title
Group difference in EQ-5D-5L at 3 to 4 months
Description
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 3 to 4 months after the fracture.
Title
Group difference in EQ-5D-5L at 1 year
Description
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.
Title
Change in EQ-5D-5L from the time of the fracture to 3 to 4 months after the fracture
Description
Change in EQ-5D-5L between groups.
Time Frame
At the time of the fracture and 3 to 4 months after the fracture.
Title
Change in EQ-5D-5L from the time of the fracture to 1 year after the fracture
Description
Change in EQ-5D-5L between groups.
Time Frame
At the time of the fracture and 1 year after the fracture.
Title
Group difference in radiographic fracture pattern- standing radiograph
Description
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.
Title
Group difference in radiographic pattern- supine computed tomography at 1 year
Description
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 1 year after the fracture.
Title
Group difference in radiographic pattern- supine computed tomography at 3 to 4 months
Description
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.
Time Frame
At 3 to 4 months after the fracture.
Title
Change in radiographic pattern- supine computed tomography - from the time of fracture to 3 to 4 months
Description
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 3 to 4 months after the fracture.
Title
Change in radiographic pattern- supine computed tomography - from 3 to 4 months to 1 year from the fracture
Description
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 to 4 months to 1 year from the fracture after the fracture.
Title
Change in radiographic pattern- supine computed tomography - from the time of fracture to 1 year
Description
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.
Title
Magnetic resonance imaging (MRI) at 1 year
Description
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 1 year after the fracture.
Title
Imaging in correlation to patient reported outcome measures at 3 to 4 months from the fracture
Description
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 3 to 4 months from the fracture
Title
Imaging in correlation to patient reported outcome measures at 1 year from the fracture
Description
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
At 1 year after the fracture.
Title
Adverse events
Description
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.
Time Frame
1 year after last subject recruitment
Title
Drug prescription/consumption
Description
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.
Time Frame
1 year after last subject recruitment
Title
Sick leave
Description
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
1 year after last subject recruitment
Title
Individual cost from the time of fracture to 3 to 4 months
Description
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 3 to 4 months after the fracture.
Title
Individual cost from the time of fracture to 1 year
Description
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.
Title
Incremental cost-effectiveness ratio
Description
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
Title
Mortality at 1 year
Description
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
1 year after last subject recruitment
Title
Mortality at 5 year
Description
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
Title
Mortality at 10 years
Description
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
Title
Oswestry Disability index (ODI) at 5 years
Description
ODI are planned to be collected at 5 years.
Time Frame
At 5 years after the fracture.
Title
Oswestry Disability index (ODI) at 10 years
Description
ODI are planned to be collected at 10 years.
Time Frame
At 10 years after the fracture.
Title
Short Musculoskeletal Function Assessment (SMFA) at 5 years
Description
SMFA are planned to be collected after 5 years.
Time Frame
At 5 years after the fracture.
Title
Short Musculoskeletal Function Assessment (SMFA) at 10 years
Description
SMFA are planned to be collected after 10 years.
Time Frame
At10 years after the fracture.
Title
EQ-5D-5L at 5 years
Description
EQ-5D-5L are planned to be collected after 5 years.
Time Frame
At 5 years after the fracture.
Title
EQ-5D-5L at 10 years
Description
EQ-5D-5L are planned to be collected after 10 years.
Time Frame
At10 years after the fracture.
Title
Sick leave at 5 years
Description
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 5 years after the fracture.
Title
Sick leave at 10 years
Description
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 10 years after the fracture.
Title
Social cost at 5 years
Description
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 5 years after the fracture.
Title
Social cost at 10 years
Description
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.
Time Frame
At 10 years after the fracture.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Blixt, MD
Phone
+46702518628
Email
simon.blixt@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Wikzén, RN
Phone
+46736994845
Email
maria.wikzén@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Gerdhem, MD, PhD
Organizational Affiliation
Uppsala University, Uppsala University Hospital and Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filip Dolatowski, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Truls Rokne Hanestad
Email
truls.rokne.hanestad@helse-bergen.no
Facility Name
Akershus University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Cetinkaya
Email
abdullah.cetinkaya@ahus.no
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Dolatowski
Phone
+4745212525
Email
fido@ous-hf.no
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Kristin Reve
Email
anne.kristin.reve@sus.no
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sivert Hammer
Email
sivert.hammer@stolav.no
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Westin, MD, PhD
Phone
+46739521538
Email
olof.westin@gmail.com
Facility Name
Halmstad Hospital
City
Halmstad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kempny, MD
Email
martin.kempny@regionhalland.se
Facility Name
Ryhov Hospital
City
Jönköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håkan Löfgren, MD, PhD
Email
hakan.lofgren@rjl.se
Facility Name
Kalmar Hospital
City
Kalmar
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Vestberg, MD
Email
erik.vestberg@regionkalmar.se
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Olai, MD
Email
anders.olai@regionostergotland.se
Facility Name
Skåne University Hospital
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders K Möller, MD, PhD
Email
anders.k.moller@skane.se
First Name & Middle Initial & Last Name & Degree
Ralph Hasserius, MD, PhD
Email
ralph.hasserius@skane.se
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Blixt, PhD Student
Phone
+46702518628
Email
simon.blixt@ki.se
First Name & Middle Initial & Last Name & Degree
Paul Gerdhem, MD, PhD
Phone
+46736994409
Email
paul.gerdhem@ki.se
Facility Name
Stockholm South General Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Eneqvist, MD, PhD
Email
ted.eneqvist@regionstockholm.se
Facility Name
University Hospital of Umeå
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Mukka, MD, PhD
Phone
+46730867111
Email
sebastian.mukka@umu.se
First Name & Middle Initial & Last Name & Degree
Lukas Bobinski, MD, PhD
Email
lukas.bobinski@umu.se
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Gerdhem, MD, PhD
Phone
+46736994409
Email
paul.gerdhem@uu.se
First Name & Middle Initial & Last Name & Degree
Monica Sjöholm, Coordinator
Phone
+46704250043
Facility Name
Central Hospital of Västerås
City
Västerås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Seikina, MD
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Joelson, MD, PhD
Email
anders.joelson@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Freyr Gauti Sigmundsson, MD, PhD
Email
freyr.sigmundsson@regionorebrolan.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD underlying published manuscripts will be accessible for other researchers.
IPD Sharing 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.
IPD Sharing 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.
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derived
Links:
URL
https://www.socialstyrelsen.se/statistik-och-data/register/patientregistret/
Description
Information on the National Board of Health and Welfare,The National Patient Register.
URL
https://www.socialstyrelsen.se/statistik-och-data/register/lakemedelsregistret/
Description
Information on the National Board of Health and Welfare, The Swedish Prescribed Drug Register.
URL
https://www.socialstyrelsen.se/statistik-och-data/register/dodsorsaksregistret/
Description
Information in Swedish on the National Board of Health and Welfare, Cause of Death Register (Socialstyrelsen. Dödsorsaksregistret.)
Learn more about this trial
StUdy oN Burst Fractures (SunBurst)
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