- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523415
Researches About Proximal Humerus Fractures
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shang Meishuang, bachelor
- Phone Number: 17303215896
- Email: 670120163@qq.com
Study Contact Backup
- Name: Guo Jialiang, Doctor
- Phone Number: 18203222090
- Email: drjlguo86@gmail.com
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Recruiting
- The Third Hospital of Hebei Medical University
-
Contact:
- Chen Wei
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with the presence of neurological disease (syringomyelia and);
- Open fractures;
- Pathological fracture (other than osteoporotic);
- Not a resident in the hospital catchment area
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients wiht CT data
all patients with CT data are enrolled with this research, and the classification about proximal humeral fractures are identified.
|
without intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
classification based on Edelson classifications
Time Frame: 2019.01-2022.12
|
2019.01-2022.12
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JLGuo001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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