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Researches About Proximal Humerus Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523415
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Third Hospital

Study Description
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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


Condition or disease Intervention/treatment
Proximal Humeral Fracture Other: without intervention, just retrospectively review the data about patients

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Reliability and Reproducibility of Edelson Classification About Proxima Humeral Fractures
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Other: without intervention, just retrospectively review the data about patients
without intervention


Outcome Measures
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Primary Outcome Measures :
  1. classification based on Edelson classifications [ Time Frame: 2019.01-2022.12 ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
proximal humeral fractures without Pathological fracture
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523415


Contacts
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Contact: Guo Jialiang, Doctor 18203222090 drjlguo86@gmail.com
Contact: Shang Meishuang, bachelor 17303215896 670120163@qq.com

Locations
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China, Hebei
the Third Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Chen Wei         
Sponsors and Collaborators
Hebei Medical University Third Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hebei Medical University Third Hospital
ClinicalTrials.gov Identifier: NCT04523415    
Other Study ID Numbers: JLGuo001
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: after the experiment was conducted
Access Criteria: all authors focusing on proximal humeral fractures

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebei Medical University Third Hospital:
Proximal Humeral
Fracture
Classifications
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
 Wounds and Injuries
Arm Injuries
Shoulder Injuries