Thoracolumbar Burst Fracture
Conditions
Keywords
Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical 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 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.
Interventions
PROCEDURESurgical 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.
Sponsors
Uppsala University
Sahlgrenska University Hospital
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group difference in Oswestry Disability Index (ODI) 1 year after the fracture. | 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
| Measure | Time frame | Description |
|---|---|---|
| Categories of Oswestry Disability Index (ODI) 1 year after the fracture | 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. |
| Group difference in Oswestry Disability Index (ODI) 1 year after the fracture, adjusted. | 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. |
| Group difference in Oswestry Disability Index (ODI) first item (pain) 1 year after the fracture | 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. |
| Group difference in Oswestry Disability Index (ODI) 3-4 months after the fracture | 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. |
| Categories of Oswestry Disability Index (ODI) 3-4 months after the fracture | 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. |
| Group difference in Oswestry Disability Index (ODI) first item (pain) 3-4 months after the fracture | 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. |
| Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 3-4 months after the fracture | At enrollment to 3-4 months after the fracture. | Change in ODI between groups. |
| Change in Oswestry Disability Index (ODI) from baseline (prior injury) to 1 year after the fracture | At enrollment to 1 year after the fracture. | Change in ODI between groups. |
| Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3-4 months | 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. |
| Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year | 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. |
| Change in Short Musculoskeletal Function Assessment (SMFA) from baseline (prior injury) to 3-4 months after the fracture | At enrollment to 3-4 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 | At enrollment to 1 year after the fracture. | Change in SMFA between groups. |
| Group difference in EQ-5D-5L at 3-4 months | 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. |
| Group difference in EQ-5D-5L at 1 year | 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. |
| Change in EQ-5D-5L from baseline (prior injury) to 3-4 months after the fracture | At enrollment to 3-4 months after the fracture. | Change in EQ-5D-5L between groups. |
| Change in EQ-5D-5L from baseline (prior injury) to 1 year after the fracture | At enrollment to 1 year after the fracture. | Change in EQ-5D-5L between groups. |
| Group difference in radiographic fracture pattern- standing radiograph | 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. |
| Group difference in radiographic pattern- supine computed tomography at 1 year | 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. |
| Group difference in radiographic pattern- supine computed tomography at 3-4 months | 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. |
| Change in radiographic pattern- supine computed tomography - from the time of fracture to 3-4 months | 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. |
| Change in radiographic pattern- supine computed tomography - from 3-4 months to 1 year from the fracture | 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. |
| Change in radiographic pattern- supine computed tomography - from the time of fracture to 1 year | 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. |
| Magnetic resonance imaging (MRI) at 1 year | 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. |
| Imaging in correlation to patient reported outcome measures at 3-4 months from the fracture | 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. |
| Imaging in correlation to patient reported outcome measures at 1 year from the fracture | 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. |
| Adverse events | 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. |
| Drug prescription/consumption | 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. |
| Sick leave | 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. |
| Individual cost from the time of fracture to 3-4 months | 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. |
| Individual cost from the time of fracture to 1 year | 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. |
| Incremental cost-effectiveness ratio | 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. |
| Mortality at 1 year | 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. |
| Mortality at 5 year | 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. |
| Mortality at 10 years | 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. |
| Oswestry Disability index (ODI) at 5 years | At 5 years after the fracture. | ODI are planned to be collected at 5 years. |
| Oswestry Disability index (ODI) at 10 years | At 10 years after the fracture. | ODI are planned to be collected at 10 years. |
| Short Musculoskeletal Function Assessment (SMFA) at 5 years | At 5 years after the fracture. | SMFA are planned to be collected after 5 years. |
| Short Musculoskeletal Function Assessment (SMFA) at 10 years | At10 years after the fracture. | SMFA are planned to be collected after 10 years. |
| EQ-5D-5L at 5 years | At 5 years after the fracture. | EQ-5D-5L are planned to be collected after 5 years. |
| EQ-5D-5L at 10 years | At10 years after the fracture. | EQ-5D-5L are planned to be collected after 10 years. |
| Sick leave at 5 years | 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. |
| Sick leave at 10 years | 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. |
| Social cost at 5 years | 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. |
| Social cost at 10 years | 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. |
Countries
Norway, Sweden
Contacts
PRINCIPAL_INVESTIGATORPaul Gerdhem, MD, PhD
Uppsala University, Uppsala University Hospital and Karolinska Institutet
STUDY_DIRECTORFilip Dolatowski, MD, PhD
Oslo University Hospital
Outcome results
None listed