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临床试验/NCT03863756
NCT03863756Unknown不适用

Contribution of EOS in the Structural Evaluation of Spondyloarthritis

Medical School of Tunisia1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Intermodality agreement

研究概览

简要总结

Spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. This repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. A new low-dose imaging system has emerged. This technique, called EOS, offers the advantage of lower irradiation associated with high images quality. Our goal through this work was to evaluate the reliability of the EOS imaging system compared to conventional radiography in the evaluation of the structural damage of SpA.

详细描述

Spondyloarthritis (SpA) is a chronic inflammatory disease that can affect the sacroiliac joints, the spine and / or the peripheral joints. It is characterized by a progressive and slow evolution over several years with a risk of ankylosis of the spine. It requires long-term follow-up of patients with repeated x-rays to assess structural damage. This repeated and cumulative exposure to radiation ionization puts at risk the radiosensitive organs that are in the field of irradiation.

EOS is a new low dose X-ray system that significantly reduces X-ray doses compared to conventional radiography. This system allows the global assessment of the entire skeleton from head to toe, static spine and lower limbs with the obtaining of two-dimensional images of high quality with the possibility of a three-dimensional reconstruction. Although the benefits of the EOS system are promising with regard to radiation dose reduction, few studies have investigated its use in SpA and little evidence has supported its reliability in assessing the structural damage caused by the disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients with Spondyloarthritis (SpA) meeting the criteria of Amor and / or Assessement of spondyloarthritis International Society (ASAS)
  • Indication of standard radiography for the follow-up of the patients.

排除标准

  • the presence of a contraindication to the performance of conventional radiography (CR) or EOS imaging
  • any disease affecting cognition
  • Patients who have had surgery on the spine and / or hip.

结局指标

主要结局

Intermodality agreement

时间窗: 6 months

measuring the intermodality agreement between EOS and conventional radiography for the assessment of both the sacro-iliac joints and the spine by using 3 scores: the modified New York criteria, the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and the Bath Ankylosing Spondylitis Radiology Index (BASRI).

次要结局

  • interreader agreement(3 months)

研究者

发起方
Medical School of Tunisia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamdi Ons

principal investigator

Medical School of Tunisia

研究点 (1)

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