Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
1 other identifier
observational
2,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 19, 2022
September 1, 2022
9 months
June 24, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The image quality rating scale score.
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.
Immediately after inclusion in the study.
Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.
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.
Immediately after the diagnosis is completed.
Study Arms (5)
Center A
Study center A that observe cohort populations (sample size=400).
Center B
Study center B that observe cohort populations (sample size=400).
Center C
Study center C that observe cohort populations (sample size=400).
Center D
Study center D that observe cohort populations (sample size=400).
Center E
Study center E that observe cohort populations (sample size=400).
Interventions
Patients with bone injury received routine and mobile DR sequential examination.
Eligibility Criteria
The population in the surrounding areas of the five centers set up in this study.
You may qualify if:
- Patients with new bone injury
You may not qualify if:
- Life threatening.
- Head injury and fracture.
- There are congenital malformations in the bone injury site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rongrong Hualead
Study Sites (4)
Center A
Beijing, Beijing Municipality, China
Xucheng He
Neimeng, China
Center C
Xinjiang, China
Center
Xizang, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guisheng Wang, Doctor
Third center of PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2022
First Posted
June 30, 2022
Study Start
January 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 31, 2022
Last Updated
September 19, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share