跳至主要内容
临床试验/NCT04601363
NCT04601363招募中不适用

Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Patient-Specific Hardware Spino-Pelvic Measurements

研究概览

简要总结

The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

详细描述

The registry follows patient during their standard of care visits. During a standard of care visit, a study subject will be required to answer questions about themselves and fill out patient reported outcome questionnaires. Spinopelvic measurements will be collect from standard of care x-rays. This registry is observational only used to address patient outcomes sagittal profile through the pre-operative, plan and post-operative events. Rod effectiveness in conjunction with other surgical implants by fusion assessment and sagittal alignment measurements. Patient outcomes in subgroups defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables. Rod curvature maintenance during the follow-up period. Better understanding of the post-operative risks and complications from the pre-operative condition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
10 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
  • Patient able to consent or assent

排除标准

  • Patient unable to sign an informed consent form
  • Patient unable to complete a self-administered questionnaire
  • Patient is pregnant or planning on becoming pregnant during the duration of their study participation
  • Patient is older than 85
  • Patient is younger than 10

结局指标

主要结局

Patient-Specific Hardware Spino-Pelvic Measurements

时间窗: Up to 4 years

The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray.

次要结局

  • Non Patient-Specific Hardware Spino-Pelvic Measurements(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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