3-D classification for proximal humerus fractures

The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures

This project uses CT-based 3-D images to test whether a three-dimensional classification helps doctors categorize displaced proximal humeral fractures in adults.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 17 Years and up
• Sex: All
• Sponsor: Hebei Medical University Third Hospital (other)
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT04523415 on ClinicalTrials.gov

What this trial studies

This is a retrospective observational review of patients with displaced proximal humeral fractures who have complete imaging and demographic records. Investigators will generate three-dimensional reconstructions (using Mimics with CT B30 data) and apply the Edelson 3-D classification to classify fracture patterns. The team will analyze interobserver reliability and reproducibility across a larger sample and correlate classification findings with available clinical data. All data are drawn from records at the Third Hospital of Hebei Medical University.

Who should consider this trial

Good fit: Adults older than 17 with displaced proximal humeral fractures treated within three weeks who have complete CT and 3-D reconstruction data and clear demographic records are the ideal candidates.

Not a fit: Patients with open or non-osteoporotic pathological fractures, documented neurologic disease (e.g., syringomyelia), incomplete imaging or records, or who are not residents of the hospital's catchment area are unlikely to benefit from or be included in this analysis.

Why it matters

Potential benefit: If the 3-D classification proves reliable in a larger sample, it could give surgeons a clearer, more reproducible way to describe fractures, aiding surgical planning and potentially improving outcomes.

How similar studies have performed: Prior smaller series using Edelson's three-dimensional classification reported reasonable interobserver reliability, but large-sample validation remains limited.

Eligibility criteria

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

Where this trial is running

Shijiazhuang, Hebei

• the Third Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Study coordinator: Guo Jialiang, Doctor

Conditions: Proximal Humeral Fracture, Proximal Humeral, Fracture, Classifications