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

Sponsor
Rongrong Hua (Other)
Overall Status
Recruiting
CT.gov ID
NCT05440435
Collaborator
(none)
2,000
Enrollment
4
Locations
12
Anticipated Duration (Months)
500
Patients Per Site
41.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: digital radiography (DR)

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Center A

Study center A that observe cohort populations (sample size=400).

Diagnostic Test: digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.
Center B

Study center B that observe cohort populations (sample size=400).

Diagnostic Test: digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.
Center C

Study center C that observe cohort populations (sample size=400).

Diagnostic Test: digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.
Center D

Study center D that observe cohort populations (sample size=400).

Diagnostic Test: digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.
Center E

Study center E that observe cohort populations (sample size=400).

Diagnostic Test: digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.

Outcome Measures

Primary Outcome Measures

  1. DR image evaluation using image quality rating scale. [Immediately after inclusion in the study.]

    To evaluate the imaging quality of mobile DR using image quality rating scale.

  2. Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis. [Immediately after the diagnosis is completed.]

    To analyze the difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with new bone injury
Exclusion Criteria:

  • Life threatening.

  • Head injury and fracture.

  • There are congenital malformations in the bone injury site.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center A Beijing Beijing China
2 Xucheng He Neimeng China
3 Center C Xinjiang China
4 Center Xizang China

Sponsors and Collaborators

  • Rongrong Hua

Investigators

  • Study Chair: Guisheng Wang, Doctor, Third center of PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rongrong Hua, Principal Investigator, General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT05440435
Other Study ID Numbers:
  • DR001
First Posted:
Jun 30, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rongrong Hua, Principal Investigator, General Hospital of Chinese Armed Police Forces
Artificial intelligence
Digital radiography

Study Results

No Results Posted as of Jun 30, 2022