SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
- 试验地点
- 17
- 主要终点
- Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Surgical
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.
干预措施: Surgical stabilization (Procedure)
Non-surgical treatment
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.
结局指标
主要结局
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.
时间窗: 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.
次要结局
- Social cost at 10 years(At 10 years after the fracture.)
- Magnetic resonance imaging (MRI) at 1 year(At 1 year after the fracture.)
- Imaging in correlation to patient reported outcome measures at 1 year from the fracture(At 1 year after the fracture.)
- Group difference in EQ-5D-5L at 1 year(At 1 year after the fracture.)
- Group difference in radiographic fracture pattern- standing radiograph(At 1 year after the fracture.)
- Short Musculoskeletal Function Assessment (SMFA) at 10 years(At10 years after the fracture.)
- EQ-5D-5L at 10 years(At10 years after the fracture.)
- Group difference in radiographic pattern- supine computed tomography at 1 year(At 1 year after the fracture.)
- Individual cost from the time of fracture to 1 year(From the time of fracture to 1 year after the fracture.)
- Sick leave at 10 years(At 10 years after the fracture.)
- Group difference in Short Musculoskeletal Function Assessment (SMFA) at 1 year(At 1 year after the fracture.)
- 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.)
- Mortality at 1 year(1 year after last subject recruitment)
- Mortality at 5 year(5 years after last subject recruitment)
- Social cost at 5 years(At 5 years after the fracture.)
- Mortality at 10 years(10 years after last subject recruitment)
- Incremental cost-effectiveness ratio(1 year after last subject recruitment)
- Short Musculoskeletal Function Assessment (SMFA) at 5 years(At 5 years after the fracture.)
- Oswestry Disability index (ODI) at 5 years(At 5 years after the fracture.)
- Oswestry Disability index (ODI) at 10 years(At 10 years after the fracture.)
- EQ-5D-5L at 5 years(At 5 years after the fracture.)
- Sick leave at 5 years(At 5 years after the fracture.)
- Adverse events(1 year after last subject recruitment)
- Drug prescription/consumption(1 year after last subject recruitment)
- Categories of Oswestry Disability Index (ODI) 1 year after the fracture(At 1 year after the fracture)
- Group difference in Oswestry Disability Index (ODI) 1 year after the fracture, adjusted.(At 1 year after the fracture.)
- Group difference in Oswestry Disability Index (ODI) first item (pain) 1 year after the fracture(At 1 year after the fracture)
- Group difference in Oswestry Disability Index (ODI) 3-4 months after the fracture(At 3-4 months after the fracture.)
- Categories of Oswestry Disability Index (ODI) 3-4 months after the fracture(At 3-4 months after the fracture)
- Group difference in Oswestry Disability Index (ODI) first item (pain) 3-4 months after the fracture(At 3-4 months after the fracture)
- 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 Oswestry Disability Index (ODI) from baseline (prior injury) to 1 year after the fracture(At enrollment to 1 year after the fracture.)
- Group difference in Short Musculoskeletal Function Assessment (SMFA) at 3-4 months(At 3-4 months after the fracture.)
- 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 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.)
- Group difference in EQ-5D-5L at 3-4 months(At 3-4 months after the fracture.)
- 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 from baseline (prior injury) to 1 year after the fracture(At enrollment to 1 year after the fracture.)
- Group difference in radiographic pattern- supine computed tomography at 3-4 months(At 3-4 months after the fracture.)
- 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.)
- 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.)
- Imaging in correlation to patient reported outcome measures at 3-4 months from the fracture(At 3-4 months from the fracture.)
- Sick leave(1 year after inclusion)
- Individual cost from the time of fracture to 3-4 months(From the time of fracture to 3-4 months after the fracture.)
研究者
Paul Gerdhem
MD, PhD, Professor
Uppsala University