Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment

Recruiting

• Conditions: Artificial Intelligence; Bone Injury
• Interventions: Diagnostic Test: digital radiography (DR)

• Registration Number: NCT05440435
• Lead Sponsor: Rongrong Hua

Brief Summary

In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients with new bone injury

Exclusion Criteria

• Life threatening.
• Head injury and fracture.
• There are congenital malformations in the bone injury site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Center B	digital radiography (DR)	Study center B that observe cohort populations (sample size=400).
Center D	digital radiography (DR)	Study center D that observe cohort populations (sample size=400).
Center A	digital radiography (DR)	Study center A that observe cohort populations (sample size=400).
Center C	digital radiography (DR)	Study center C that observe cohort populations (sample size=400).
Center E	digital radiography (DR)	Study center E that observe cohort populations (sample size=400).

Primary Outcome Measures

Name	Time	Method
The image quality rating scale score.	Immediately after inclusion in the study.	There are 24 entries in the image quality rating scale with a total score of 100 points. According to the score, there are 4 grades (A. ≥90; B. 80-89; C. 70-79; D. \<70), among which D is unqualified.
Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.	Immediately after the diagnosis is completed.	Sensitivity is the percentage of individuals with bone injury who diagnosed by artificial intelligence or experts. Specificity is the percentage of those without bone injury who have normal diagnosis results.

Trial Locations

Locations (4)

Center A; 🇨🇳 Beijing, Beijing, China

Center C; 🇨🇳 Xinjiang, China

Center; 🇨🇳 Xizang, China

Xucheng He; 🇨🇳 Neimeng, China