跳至主要内容
临床试验/NCT06706908
NCT06706908进行中(未招募)不适用

Innovative Spinopelvic Solutions With Real-world Evidence

SI-BONE, Inc.2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
SI-BONE, Inc.
入组人数
1,000
试验地点
2
主要终点
Change in patient reported outcomes

研究概览

简要总结

INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 21 at time of screening.
  • Patient will undergo a procedure utilizing an iFuse Implant family product.
  • Patient is comfortable communicating in written and spoken English.
  • Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
  • Patient is willing and able to provide informed consent to participate

排除标准

  • Patient has fibromyalgia.
  • Patient has a pain pump.
  • Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation

结局指标

主要结局

Change in patient reported outcomes

时间窗: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.

Change in pain as rated on a numerical rating scale (NRS), 0 being no pain and 10 being the worst pain imaginable at baseline and follow-up timepoints.

次要结局

  • Change in patient reported outcomes(At the following timepoints: 1-, 3-, 6-, and 12-months.)

研究者

发起方
SI-BONE, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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