Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Augmented reality sonography is less time consuming
研究概览
简要总结
The goal of this clinical trial is to prospectively evaluate the potential benefits of injections with Augmented Reality enhanced Ulrasound versus standard Ultrasound or fluoroscopy participants where assigend for fluoroscopic joint injections oder for Ultrasound guided injection.
The main question[s] it aims to answer are:
- The primary objective is to evaluate the duration of the different interventions
- the count of needle passes
- assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections
详细描述
Patients assigned for standard Ultrasound or fluoroscopic joint injection are informed about the trial. Participants are randomly assigned to the study or control intervention. 1:1 randomization is used.
In both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The assignment into the study groups is going to be performed by 1:1 randomization using randomisation cards which are drawn by author-ised study staff.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Patients 18 to 99 years of age
- •Patients assigned for fluoroscopic guided injections (including MR arthrographies)
- •Patients assigned for US guided injections (including MR arthrographies)
排除标准
- •- Patients who are not willing to be part of the study
- •Contraindication against fluoroscopic guided injection
- •Women who are pregnant or breast feeding (Pregnancy assessment is part of the routine prior to fluoroscopic joint injections. No pregnancy test will be done for this study.)
结局指标
主要结局
Augmented reality sonography is less time consuming
时间窗: 10 minutes
Puncturing shoulders with Augmented reality sonography is faster (measuring the time in minutes and seconds) than when using standard sonography- from point of entry the skin until the target
次要结局
- Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing(10 minutes (ml aspirated) to 3 days (laboratory results))