跳至主要内容
临床试验/NCT05366140
NCT05366140招募中不适用

Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.

Francis Farhadi1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
clinical prospective review- Prospective Database study for future studies

研究概览

简要总结

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

详细描述

To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.

Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients, 18 years of age and older
  • Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery.

排除标准

  • Individuals who have not yet reached the age of 18.

结局指标

主要结局

clinical prospective review- Prospective Database study for future studies

时间窗: 5- years

Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.

次要结局

未报告次要终点

研究者

发起方
Francis Farhadi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francis Farhadi

Associate Professor

University of Kentucky

研究点 (1)

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