Bone InjuryNCT05440435
Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
An observational study of Bone Injury and Artificial Intelligence, run by Rongrong Hua at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bone Injury, Artificial Intelligence
- What is being tested?
- digital radiography (DR)
- How many people
- 2,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The population in the surrounding areas of the five centers set up in this study.
Who may be able to join
- Patients with new bone injury
Who cannot join
- Life threatening.
- Head injury and fracture.
- There are congenital malformations in the bone injury site.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Center A
Beijing, Beijing Municipality
Rongrong Hua, Dr., +8615810159356, huarongrong1011@163.com
- Recruiting
Xucheng He
Neimeng
Xucheng He
- Recruiting
Center C
Xinjiang
Xucheng He
- Recruiting
Center
Xizang
Xucheng He
About this study
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.
- Conditions
- Bone Injury, Artificial Intelligence
- Being tested
- digital radiography (DR)
- Keywords
- Artificial intelligence, Digital radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital radiography (DR)Diagnostic test
Patients with bone injury received routine and mobile DR sequential examination.
| Study group | Role | What they receive |
|---|---|---|
| Center A | Study center A that observe cohort populations (sample size=400). Receives: Diagnostic Test: digital radiography (DR) | |
| Center B | Study center B that observe cohort populations (sample size=400). Receives: Diagnostic Test: digital radiography (DR) | |
| Center C | Study center C that observe cohort populations (sample size=400). Receives: Diagnostic Test: digital radiography (DR) | |
| Center D | Study center D that observe cohort populations (sample size=400). Receives: Diagnostic Test: digital radiography (DR) | |
| Center E | Study center E that observe cohort populations (sample size=400). Receives: Diagnostic Test: digital radiography (DR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the diagnosis is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rongrong Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rongrong Hua, General Hospital of Chinese Armed Police Forces
- Investigators
- Guisheng Wang, Doctor, Study chair, Third center of PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440435
- Sponsor's protocol ID
- DR001
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
- ClinicalTrials.gov ID
- NCT05440435
- Acronym / sponsor ID
- DR001
- Conditions
- Bone Injury, Artificial Intelligence
- Keywords
- Artificial intelligence, Digital radiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Rongrong HuaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Center A | – | Diagnostic Test: digital radiography (DR)Study center A that observe cohort populations (sample size=400). |
| Center B | – | Diagnostic Test: digital radiography (DR)Study center B that observe cohort populations (sample size=400). |
| Center C | – | Diagnostic Test: digital radiography (DR)Study center C that observe cohort populations (sample size=400). |
| Center D | – | Diagnostic Test: digital radiography (DR)Study center D that observe cohort populations (sample size=400). |
| Center E | – | Diagnostic Test: digital radiography (DR)Study center E that observe cohort populations (sample size=400). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population in the surrounding areas of the five centers set up in this study.
Key inclusion criteria (1 listed)
- Patients with new bone injury
Key exclusion criteria (3 listed)
- Life threatening.
- Head injury and fracture.
- There are congenital malformations in the bone injury site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital radiography (DR)Patients with bone injury received routine and mobile DR sequential examination. | Diagnostic test | Center A, Center B, Center C, Center D, Center E |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guisheng Wang, Doctor study chair
Third center of PLA General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Injury and Artificial Intelligence, run by Rongrong Hua at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Hua, Doctor (0086-15810159356, huarongrong1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The image quality rating scale score. (time frame: Immediately after inclusion in the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.