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

September 15, 2022 updated by: Rongrong Hua
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Neimeng, China
        • Recruiting
        • Xucheng He
        • Contact:
          • Xucheng He
      • Xinjiang, China
        • Recruiting
        • Center C
        • Contact:
          • Xucheng He
      • Xizang, China
        • Recruiting
        • Center
        • Contact:
          • Xucheng He
    • Beijing
      • Beijing, Beijing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population in the surrounding areas of the five centers set up in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The image quality rating scale score.
Time Frame: 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.
Immediately after inclusion in the study.
Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.
Time Frame: 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.
Immediately after the diagnosis is completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rongrong Hua

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (ACTUAL)

June 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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