Researches About Proximal Humerus Fractures

Proximal Humeral Fracture Clinical Trial

Official title:

The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523415
• Other study ID #: JLGuo001
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Hebei Medical University Third Hospital
• Contact: Guo Jialiang, Doctor
• Phone: 18203222090
• Email: drjlguo86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Other:
• without intervention, just retrospectively review the data about patients
without intervention

Locations

Country	Name	City	State
China	the Third Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	classification based on Edelson classifications		2019.01-2022.12