临床试验/NCT01338493

NCT01338493已完成不适用

Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study

Medtronic Spinal and Biologics13 个研究点分布在 3 个国家目标入组 139 人开始时间: 2009年2月最近更新: 2016年1月28日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 139
试验地点: 13
主要终点: Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)

时间窗: 6 months

The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.

次要结局

Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)(6 months)

研究者

发起方

Medtronic Spinal and Biologics

申办方类型

Industry

责任方

Sponsor

研究点 (13)

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