Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
研究概览
简要总结
Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms.
The study's precise objectives are to:
- evaluate the clinical outcome (Oswestry Disability Index)
- evaluate the radiography result (restoration and maintenance of spinal alignment)
- determine the prevalence of complications
at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.
详细描述
The research is a single-center, nationwide, randomized controlled trial. Over a two-year period, 52 patients with a thoracolumbar burst fracture will enroll in the study. They will be assigned randomly (1:1) to either non-surgical treatment with a brace or surgery with anterior-posterior fixation. A prospective data collection will be asked of subjects who decline randomization (observational arm). The subjects will be evaluated clinically, radiologically, and based on patient-reported outcomes over the course of two years. Both patient files and questionnaires will be used to collect data.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years at inclusion
- •Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
- •Informed consent for study participation
排除标准
- •Injury of the posterior tension band/posterior column of the thoracolumbar spine
- •Any neurological deficit (American Spinal Injury Association Impairment Scale [AISA] Grade A-D)
- •Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- •Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- •Multiple trauma or Injury Severity Score (ISS) > 16 or additional injuries according to the investigator may, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study (impairment of early ambulation)
- •Any known previous spinal surgery in the thoracolumbar spine, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- •Any severe, progressive, or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study
- •Known history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment in the opinion of the investigator
- •Pregnancy or women planning to conceive within the study period. All women included in this study must have a negative blood pregnancy test (human chorionic gonadotrophin (hCG) blood level at visit
- •If pregnancy occurs during the study period, the patients drop out of the study
- •Inability to follow the procedures of the study, e.g., due to inability to understand German, French or English, which, according to the investigator, may jeopardize the patient in case of participation in the study or prevents the patient from participating in the study
结局指标
主要结局
The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
时间窗: 2 years after 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
- Radiological outcome: Segment mobility(52 weeks after fracture)
- Radiological outcome: Progression of spinal canal stenosis(From the time of fracture, 26 weeks and 52 weeks)
- Indirect costs(6, 12, 26, 52, and 104 weeks)
- Radiological outcome: Spinal fusion and fracture consolidation(26 weeks after fracture)
- Radiological outcome: Degeneration of the intervertebral disc over time(Pre-Treatment, 52 weeks after the fracture)
- Complication rate and severity and additional surgeries(6, 12, 26, 52, and 104 weeks)
- Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST)(From the time of fracture to 2 years after the fracture)
- Changes in patient-related outcome measurements: EQ5D-3L(Pre-Treatment to 2 years after the fracture)
- Changes in patient-related outcome measurements: Pain visual analogue scale (VAS)(Pre-Treatment to 2 years after the fracture)
- Treatment data: Length of hospitalization (days)(Pre-Treatment to discharge from hospital)
- Treatment data: blood loss during surgery (ml)(during surgery)
- Treatment data: duration of surgery (hh: mm)(during surgery)
- Time to return to work/sports(6, 12, 26, 52, and 104 weeks)
- Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle(Pre-Treatment to 2 years after the fracture)
- Non-surgical treatment failure rate(From the time of fracture to 2 years after the fracture)
- Radiological outcome: Sagittal and coronal alignment(6, 12, 26, 52, and 104 weeks)
- Opioid use(Pre-Treatment, 6, 12, 26, 52, and 104 weeks)