跳至主要内容
临床试验/NCT06644391
NCT06644391已完成不适用

A Retrospective Multi-reader Study of Diagnostic Performance: Carebot AI Bones 1.2 (Deep Learning Algorithms v1.0), Frýdek-Místek Hospital

Carebot s.r.o.1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Sensitivity of AI Model Compared to Radiologists in Fracture Detection on Musculoskeletal X-rays

研究概览

简要总结

This retrospective study aims to evaluate the effectiveness of artificial intelligence (AI) in identifying fractures on musculoskeletal X-rays. By comparing the performance of a deep learning AI model with that of experienced radiologists, we seek to understand how AI can help improve fracture detection accuracy in clinical settings. The study analyzed 600 X-rays from both pediatric and adult patients, focusing on identifying fractures across different body parts, including the foot, ankle, knee, hand, wrist, and more. The findings show that integrating AI can increase radiologists' sensitivity in detecting fractures, potentially improving patient outcomes by reducing the number of missed injuries.

研究设计

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

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 1 year or older.
  • Musculoskeletal X-rays available in Digital Imaging and Communications in Medicine (DICOM) format.
  • At least one digital plain radiograph of an appendicular body part, including the foot, ankle, knee, hand, wrist, elbow, shoulder, or pelvis.

排除标准

  • Poor radiographic quality that precludes human interpretation.
  • Radiographs of the lumbar, thoracic, and cervical spine, or facial/nasal bones.
  • Radiographs that do not meet the inclusion criteria for appendicular body parts.

研究组 & 干预措施

Radiographs Analyzed Using AI and Radiologist Review

This cohort consists of 600 radiographs collected from pediatric and adult patients, aged 1 to 99 years, who underwent X-ray imaging for musculoskeletal conditions. The radiographs include various body parts such as the foot, ankle, knee, hand, wrist, elbow, shoulder, and pelvis. Fractures were present in 95 cases, while 453 cases showed no fractures.

干预措施: Carebot AI Bones (Diagnostic Test)

结局指标

主要结局

Sensitivity of AI Model Compared to Radiologists in Fracture Detection on Musculoskeletal X-rays

时间窗: From March 2023 to May 2023 (Retrospective analysis period)

This outcome measures the sensitivity of the AI model (Carebot AI Bones 1.2.2) in detecting fractures on musculoskeletal X-rays, compared to the sensitivity of radiologists with varying levels of experience. Sensitivity is calculated as the proportion of true positive fracture cases identified by the AI model and radiologists out of all confirmed fracture cases.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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