StUdy oN Burst Fractures (SunBurst)

Study Overview
=================
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.

Official Title
-----------------
SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures

Conditions
-----------------
Thoracolumbar Burst Fracture

Intervention / Treatment
-----------------
* Procedure: Surgical stabilization


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical<br>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<br>* 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.<br>|
| No Intervention: Non-surgical treatment<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 to 4 months after the fracture. | 
| 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. | At the time of the fracture and 3 to 4 months after the fracture. | 
| Change in Oswestry Disability Index (ODI) from the time of the fracture to 1 year after the fracture | Change in ODI between groups. | At the time of the fracture and 1 year after the fracture. | 
| 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. | At 3 to 4 months after the fracture. | 
| 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. | At 1 year after the fracture. | 
| 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. | At the time of the fracture and 3 to 4 months after the fracture. | 
| Change in Short Musculoskeletal Function Assessment (SMFA) from the time of the fracture to 1 year after the fracture | Change in SMFA between groups. | At the time of the fracture and 1 year after the fracture. | 
| 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. | At 3 to 4 months after the fracture. | 
| 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. | At 1 year after the fracture. | 
| 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. | At the time of the fracture and 3 to 4 months after the fracture. | 
| Change in EQ-5D-5L from the time of the fracture to 1 year after the fracture | Change in EQ-5D-5L between groups. | At the time of the fracture and 1 year after the fracture. | 
| 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. | At 1 year after the fracture. | 
| 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. | At 1 year after the fracture. | 
| 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. | At 3 to 4 months after the fracture. | 
| 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. | From the time of fracture to 3 to 4 months after the fracture. | 
| 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. | From 3 to 4 months to 1 year from the fracture after the fracture. | 
| 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. | From the time of fracture to 1 year after the fracture. | 
| 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. | At 1 year after the fracture. | 
| 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 | At 3 to 4 months from the fracture | 
| 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. | At 1 year after the fracture. | 
| 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. | 1 year after last subject recruitment | 
| 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. | 1 year after last subject recruitment | 
| 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. | 1 year after last subject recruitment | 
| 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. | From the time of fracture to 3 to 4 months after the fracture. | 
| 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. | From the time of fracture to 1 year after the fracture. | 
| 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. | 1 year after last subject recruitment | 
| 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. | 1 year after last subject recruitment | 
| 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. | 5 years after last subject recruitment | 
| 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. | 10 years after last subject recruitment | 
| Oswestry Disability index (ODI) at 5 years | ODI are planned to be collected at 5 years. | At 5 years after the fracture. | 
| Oswestry Disability index (ODI) at 10 years | ODI are planned to be collected at 10 years. | At 10 years after the fracture. | 
| Short Musculoskeletal Function Assessment (SMFA) at 5 years | SMFA are planned to be collected after 5 years. | At 5 years after the fracture. | 
| Short Musculoskeletal Function Assessment (SMFA) at 10 years | SMFA are planned to be collected after 10 years. | At10 years after the fracture. | 
| EQ-5D-5L at 5 years | EQ-5D-5L are planned to be collected after 5 years. | At 5 years after the fracture. | 
| EQ-5D-5L at 10 years | EQ-5D-5L are planned to be collected after 10 years. | At10 years after the fracture. | 
| 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. | At 5 years after the fracture. | 
| 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. | At 10 years after the fracture. | 
| 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. | At 5 years after the fracture. | 
| 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. | At 10 years after the fracture. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracolumbar spine, Burst fractures, Thoracic or lumbar vertebrae, Register-based, Randomized controlled trial, Conservative treatment, Surgical treatment, Non-surgical treatment