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临床试验/NCT04752007
NCT04752007已完成不适用

Accuracy of the CT-Implant Movement Analysis. A Feasibility Study.

University of Bergen1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
1
主要终点
Movement of the SI joint in mikrometer

研究概览

简要总结

Movement of the Sacroiliac (SI) Joint, comparing conventional RSA with the Sectra Implant Movement analysis using a low dose CT for high accuracy measurement. A feasibility study for a future kohort study.

详细描述

Abstract Background: Radiostereometric analysis (RSA) is a high precision in vivo measuring method and regarded as the gold standard for motion analysis. RSA has been around for over 40 years and its accuracy is properly evaluated. The CT technics have evolved and now low dose CT scans can reproduce 3-D models of bone and joints. The Sectra Implant Movement analysis (IMA) is a new method using a low dose CT for high accuracy measurement. There is no study evaluating the precision and accuracy of the new CT based method.The investigator want to compare the accuracy of the two methods.

Method/design: The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies conducted at Ullevål University Hospital. There are 2-6 patients in the age of 40-50 years available for RSA analysis with and without provocation of the SI joints. Some are fused in one SI joint after insertion of the tantalum markers, but the contralateral joint can then be used for the analysis. At the same time,the investigator will perform low dose CT with and without provocation of the SI joints. The results of the analysis will be compared.

Discussion: The conventional RSA is an invasive method using tantalum markers inserted in to bone. If the CT method has the same accuracy, then the tantalum markers will become obsolete and future studies can easily be performed using non-invasive low dose CT scans.

Keywords: RSA, CT method, low dose CT, IS joint, movement

Introduction:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies, approximately five years ago, conducted at Ullevål University Hospital.

排除标准

  • The patients that can not perfome the provocation images of the SI joints.
  • Pregnancy
  • Not able to or do not want to participate

结局指标

主要结局

Movement of the SI joint in mikrometer

时间窗: 4 weeks

Movement analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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