Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
研究概览
简要总结
The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.
详细描述
Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine [vertebra] breaks due to immediate and severe compression).
The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
- •Neurologically intact
- •TLICS score of 4
- •Women of childbearing potential must have a negative serum pregnancy test
排除标准
- •Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours)
- •Sepsis and/or organ failure
- •Prior instrumented arthrodesis of the thoracolumbar spine
- •Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- •Recent history (<3 years) of concomitant spinal tumor or infection
- •Greater than single level fracture involvement (other than transverse process fractures)
- •AO Type A3 fracture with associated load sharing score ≥7
- •≥ 30 degrees regional kyphosis on standing
- •History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis)
- •History of osteoporosis
- •Subjects who are pregnant or plan to become pregnant in the next 24 months. Patients will be advised on the use of contraceptives during this time. Methods include abstinence or two acceptable forms including condoms with spermicide, birth control pills, injections, or an IUD.
- •Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate)
- •Severe morbid obesity (BMI > 40)
- •History of metal sensitivity/foreign body sensitivity
- •History of prior laminectomy at the fracture site
- •Associated scoliotic (> 10°) or pre-existing thoracolumbar kyphotic deformity
- •History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
结局指标
主要结局
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
时间窗: 2 years
Primary Outcome is to compare radiologic and clinical outcomes. These will be measured by regional kyphosis, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients; and Oswestry Disability Index, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
次要结局
- Compare radiologic outcomes using regional kyphosis(5 and 10 years)
- Evaluate clinical outcomes using questionnaires(5 and 10 years)
- Compare Health Care Cost between both groups over 10 years(10 years)
- Compare global sagittal balance at 3 different time points(2,5, and 10 years)
- Collect data on patient in both groups for 10 years(10 years)
- Compare Return to work rates over a two year peiord(3 month, 1 year, and 2 years)
研究者
H Francis Farhadi
Assistant Professor
Ohio State University