跳至主要内容
临床试验/NCT05318378
NCT05318378Unknown不适用

Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students

Centre de l'arthrose, Paris2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Sensibility, specificity,

研究概览

简要总结

Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.

Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

We built two series of images. Series one was composed of separated conventional and inverted images. Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together (Figure). An independent assessor randomly duplicated four and two images for series one and two, respectively, to evaluate the intra-observer agreement. The same assessor randomized the images' order of appearance for the two series with a free online available list randomizer (www.randomizer.org). The principal investigator was blinded to the randomization during the sessions.

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

  • fifth-year medical students

排除标准

  • other medical students

结局指标

主要结局

Sensibility, specificity,

时间窗: one month

Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test

accuracy

时间窗: one month

accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test

次要结局

未报告次要终点

研究者

发起方
Centre de l'arthrose, Paris
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验