Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index.
研究概览
简要总结
Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure.
Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made
详细描述
To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.
This study is part of a larger Continuous Quality Improvement initiative at the Columbia Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. Through an iterative feedback process we hope to optimize patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Standard of care
排除标准
- •Standard of care
结局指标
主要结局
Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index.
时间窗: 2 years
次要结局
未报告次要终点
研究者
John Miles, MD
Investigator
Columbia Orthopaedic Group, LLP