Proximal Humeral FractureNCT04523415
Researches About Proximal Humerus Fractures
An observational study of Proximal Humeral Fracture, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- without intervention, just retrospectively review the data about patients
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: proximal humeral fractures without Pathological fracture
Who may be able to join
- Whole imaging data ;
- Clear record of demographic data;
- Three dimensional construction with mimics (with CT of B30);
- Patients older than 17 years with displaced PHF occurring less than 3 weeks before allocation and treatment.
Who cannot join
- Patients with the presence of neurological disease (syringomyelia and);
- Open fractures;
- Pathological fracture (other than osteoporotic);
- Not a resident in the hospital catchment area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Chen Wei
About this study
Official title: The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures
Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. Furthermore, CT and 3-D CT construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. Edelson proposed a new three-dimensional classification for fractures of the proximal humerus. The results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability.
It could be hypothesized that patients with proximal humeral fractures would benefit from this 3D classification, but there is a scarcity of application of the classification in large samples. T
- Conditions
- Proximal Humeral Fracture
- Being tested
- without intervention, just retrospectively review the data about patients
- Keywords
- Proximal Humeral, Fracture, Classifications
- Medical subject headings
- Shoulder Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without intervention, just retrospectively review the data about patientsOther
without intervention
| Study group | Role | What they receive |
|---|---|---|
| patients wiht CT data | all patients with CT data are enrolled with this research, and the classification about proximal humeral fractures are identified. Receives: Other: without intervention, just retrospectively review the data about patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
classification based on Edelson classifications
Measured: 2019.01-2022.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523415
- Sponsor's protocol ID
- JLGuo001
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures
- ClinicalTrials.gov ID
- NCT04523415
- Acronym / sponsor ID
- JLGuo001
- Conditions
- Proximal Humeral Fracture
- Keywords
- Proximal Humeral, Fracture, Classifications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Aug 2020 (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.
Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. Furthermore, CT and 3-D CT construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. Edelson proposed a new three-dimensional classification for fractures of the proximal humerus. The results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability.
It could be hypothesized that patients with proximal humeral fractures would benefit from this 3D classification, but there is a scarcity of application of the classification in large samples. T
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients wiht CT data | – | Other: without intervention, just retrospectively review the data about patientsall patients with CT data are enrolled with this research, and the classification about proximal humeral fractures are identified. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- proximal humeral fractures without Pathological fracture
Key inclusion criteria (4 listed)
- Whole imaging data ;
- Clear record of demographic data;
- Three dimensional construction with mimics (with CT of B30);
- Patients older than 17 years with displaced PHF occurring less than 3 weeks before allocation and treatment.
Key exclusion criteria (4 listed)
- Patients with the presence of neurological disease (syringomyelia and);
- Open fractures;
- Pathological fracture (other than osteoporotic);
- Not a resident in the hospital catchment area
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 |
|---|---|---|
| without intervention, just retrospectively review the data about patientswithout intervention | Other | patients wiht CT data |
Primary outcome
classification based on Edelson classifications
Time frame: 2019.01-2022.12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Hebei Medical University Third Hospital at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo Jialiang, Doctor (18203222090, drjlguo86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
classification based on Edelson classifications (time frame: 2019.01-2022.12). 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 23 Jan 2026.