NCT05440435

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

June 24, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

Artificial intelligenceDigital radiography

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).

Diagnostic Test: digital radiography (DR)

Center B

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

Diagnostic Test: digital radiography (DR)

Center C

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

Diagnostic Test: digital radiography (DR)

Center D

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

Diagnostic Test: digital radiography (DR)

Center E

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

Diagnostic Test: digital radiography (DR)

Interventions

Patients with bone injury received routine and mobile DR sequential examination.

Center ACenter BCenter CCenter DCenter E

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Study Sites (4)

Center A

Beijing, Beijing Municipality, China

RECRUITING

Xucheng He

Neimeng, China

RECRUITING

Center C

Xinjiang, China

RECRUITING

Center

Xizang, China

RECRUITING

MeSH Terms

Interventions

Radiographic Image Enhancement

Intervention Hierarchy (Ancestors)

Image EnhancementPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiography

Study Officials

  • Guisheng Wang, Doctor

    Third center of PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Rongrong Hua, Doctor

CONTACT

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

Locations