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临床试验/NCT02611479
NCT02611479已完成不适用

Understanding Non-Response in Spine Fusion Surgery

University of Washington4 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
4
主要终点
Oswestry Disability Index

研究概览

简要总结

To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).

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

入选标准

  • Subject has diagnosis of degenerative disc disease
  • Subject is undergoing lumbar spine fusion surgery

排除标准

  • Subject is less than 18 years of age
  • Subject is not fluent in English
  • Subject requires a caretaker for medical decision making

结局指标

主要结局

Oswestry Disability Index

时间窗: Baseline, 60 day, 1 year

Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Flum

Medical Director, Surgical Outcomes Research Center

University of Washington

研究点 (4)

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