Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 14
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.
详细描述
208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC) injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study. Patients may have an associated B injury, but must have an A3 or A4. Patients will be monitored prospectively for patient reported, clinical and radiologic outcomes, over a period of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability Index (ODI), and employment information (indirect costs questionnaire) every second week until 6 months post-treatment. Diary will continue every second month until 2 years post-treatment. All interventions/examinations are considered as standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature, age 18 to 65 years old inclusive
- •Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC injury (M1) from T10 to L
- •Patients may have an associated B injury, but must have an A3 or A
- •TLICS Score between 2-5 inclusive
- •Acute fracture - diagnosis and treatment within 10 days of injury
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the clinical investigation including imaging and FU procedures
- •Investigation according to the Clinical Investigation Plan (CIP)
- •Signed and dated IRB/EC-approved written informed consent
排除标准
- •Any neurological deficit associated with the fracture. Absence of neurological deficit will be determined with the International Standards for Neurological Classification of Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically intact/normal) of the patient.
- •Spontaneous fractures due to pathologic processes or neoplasia
- •Head injuries causing inability to cooperate during hospital admission
- •Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
- •Prior spinal surgeries in thoracic or lumbar spine
- •Additional musculoskeletal, head or other injuries which would preclude rapid mobilization
- •Multiple trauma or Injury Severity Score (ISS) > 16
- •Other co-morbidities precluding the patient to be considered as a surgical or non-surgical candidate, i.e. burns, dementia, BMI > 40, etc.
- •Any severe systemic medical disease that would exclude the patient to be a potential candidate for surgery
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment.
- •Pregnancy or women planning to conceive within the study period
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 1 year
ODI within the first year after surgical or non-surgical treatment using time to event analysis
次要结局
- AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)(2 years)
- Surgical treatment failure rate(2 years)
- indirect cost questionnaire(2 years)
- Quality of life EQ5D-3L(2 years)
- Numeric Pain Rating Scale (NPRS)(2 years)
- overall satisfaction with the treatment(2 years)
- Spine Adverse Events Severity System (SAVES)(2 years)
- Non-surgical treatment failure rate(2 years)
- Validation of AO TL Classification System aided by the analysis of CT scans(2 years)