NCT01024699已完成不适用
A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared With MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis
NuVasive8 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.
研究概览
简要总结
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.
详细描述
The study is a prospective multi-center randomized evaluation of clinical and radiographic outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult patients with low-grade symptomatic spondylolisthesis. The study seeks to identify differences between the procedures with respect to perioperative variables.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Male and female patients who are at least 18 years of age;
- •- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1 or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain;
- •- Patients who have been unresponsive to at least 6 months of conservative treatments or exhibit progressive neurological symptoms in the face of conservative treatment;
- •- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
排除标准
- •- Patients with lumbar pathologies requiring treatment at more than 2 levels;
- •- Patients who have had previous lumbar fusion surgery;
- •- Patients with lytic spondylolisthesis or a defect of the pars interarticularis;
- •- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration;
- •- Patients with non-contained or extruded herniated nucleus pulposus
结局指标
主要结局
The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.
时间窗: 24 months
次要结局
- The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.(24 months)
研究者
研究点 (8)
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