Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain
研究概览
简要总结
The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).
详细描述
Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a primary 1- to 2-level ACDF
- •(a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- •Patients able to provide informed consent
排除标准
- •Cervical spine trauma
结局指标
主要结局
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain
时间窗: 6 months
Patients will be asked to complete the VAS to measure their pain prior to surgery and at their preoperative office visit(s) or just prior to surgery in the preoperative waiting area. Scores at the 6 month follow up office visit will be compared to baseline
次要结局
- Dysphagia(6 months)
- Fusion Rates(6 months)
- Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months(6 months)
- Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months(6 months)
研究者
Carla Edwards
Clinical Research Manger
Rush University Medical Center