跳至主要内容
临床试验/NCT06351943
NCT06351943进行中(未招募)不适用

Validation of the Fracture Classification Accuracy (Ground Truth) of Anteroposterior X-ray of the Proximal Femur According to the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association Classification Done by a Single Center: A Pilot Validation Study

AO Innovation Translation Center1 个研究点 分布在 1 个国家目标入组 2,932 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,932
试验地点
1
主要终点
In case of fracture, AO/OTA classification: Qualifier for 31B2

研究概览

简要总结

The AO@AI Turin project is a collaborative project with a Turin group and the AO (Arbeitsgemeinschaft für Osteosynthesefragen, or in English, Association for the Study of Internal Fixation) foundation. An Image database (DB) has been built to host AP pelvic radiographs ready for artificial intelligence (AI) development.

The goal of this project is to determine the agreement between the Turin annotation of fracture status and the annotation from an external group of AO expert surgeons for a random subset of the Turin images.

详细描述

The AO@AI Turin project is a collaborative project with a Turin group who has collected 2,932 anteroposterior (AP) pelvic radiographs, of which 1,811 are fracture images, and 1,121 are non-fracture images. The Turin group has developed an artificial intelligence (AI) algorithm for fracture classification using these images. These anonymized images (with all metadata or personal identifiers removed) have been uploaded to a cloud-based image database (DB) hosted and managed by the AO Foundation.

The Turin group has established the "ground truth" using the methods of "consensus by experts". Two radiologists from their medical team have reviewed and classified the fracture status (fracture vs non-fracture, and, if fracture, the AO/Orthopedic Trauma Association [OTA] classification).

The next step's goal is the ground truth validation plan to test the accuracy of the Turin annotation of fracture classification of the already uploaded AP pelvic images. This is to ensure that the image DB offers accurate quality annotations to allow AI development.

For the pilot phase, a random subset of the Turin images (300 of images) will be drawn from the image DB. These images will be reviewed by an external group of AO expert surgeons who will annotate the images per their fracture status, i.e., fracture vs non-fracture, and, if fracture, the AO/OTA classification.

The group of AO expert surgeons consists of four surgeons who will independently review the 300 images and a fifth surgeon who serves as an adjudicator if necessary. The expert surgeons will be given access to the 300 images via the cloud-based image DB and annotate the images. The expert surgeons will be blinded to the Turin annotations. The expert surgeons' annotations will be entered into a DB built for the purpose for the pilot study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

In case of fracture, AO/OTA classification: Qualifier for 31B2

时间窗: Day 0/Baseline

AO/OTA classification: Qualifier for 31B2: p/q/r

Annotations of fracture status of the image

时间窗: Day 0/Baseline

Fracture status (fracture vs no fracture) classification

In case of fracture, Arbeitsgemeinschaft für Osteosynthesefragen (AO, in English, Association for the Study of Internal Fixation)/Orthopedic Trauma Association (OTA) classification: Type

时间窗: Day 0/Baseline

AO/OTA classification: Type: 31A/31B/31C

In case of fracture, AO/OTA classification: Group

时间窗: Day 0/Baseline

AO/OTA classification: Group: A1/A2/A3, B1/B2//B3, C1/C2

In case of fracture, AO/OTA classification: Subgroup

时间窗: Day 0/Baseline

AO/OTA classification: Subgroup: A1.1/A1.2/A1.3/A2.2/A2.3/A3.1/A3.2/A3.3/B1.1/B1.2/B1.3/B2.1/B2.2/B2.3/C1.1/C1.2/C1.3/C2.1/C2.2/C2.3

In case of fracture, AO/OTA classification: Qualifier for 31A1.1

时间窗: Day 0/Baseline

AO/OTA classification: Qualifier for 31A1.1: n/o

次要结局

未报告次要终点

研究者

发起方
AO Innovation Translation Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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