NCT04523415

Brief 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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 23, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

August 19, 2020

Last Update Submit

January 21, 2026

Conditions

Keywords

Proximal HumeralFractureClassifications

Outcome Measures

Primary Outcomes (1)

  • classification based on Edelson classifications

    2019.01-2022.12

Study Arms (1)

patients wiht CT data

all patients with CT data are enrolled with this research, and the classification about proximal humeral fractures are identified.

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

Interventions

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

proximal humeral fractures without Pathological fracture

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with the presence of neurological disease (syringomyelia and);
  • Open fractures;
  • Pathological fracture (other than osteoporotic);
  • Not a resident in the hospital catchment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Shoulder FracturesFractures, Bone

Interventions

Methods

Condition Hierarchy (Ancestors)

Wounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Guo Jialiang, Doctor

CONTACT

Shang Meishuang, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 21, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion

March 31, 2026

Last Updated

January 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
after the experiment was conducted
Access Criteria
all authors focusing on proximal humeral fractures

Locations