- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03023956
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
January 22, 2017 updated by: Xiaoxiao Zhou
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital.
According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups.
All the patients were followed at least 1 year.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
31
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Description
Inclusion Criteria:
-From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Exclusion Criteria:
- Patients had pathologic fractures,
- Patients had previous surgery on the affected shoulder,
- Patients were treated with shoulder arthroplasty.
- Patients were treated with intramedullary nail.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ANF
anatomic neck fractures of proximal humerus
|
|
|
SNF
surgical neck fractures of proximal humerus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change of head-shaft angle at 12months from 6months in two groups
Time Frame: 12months
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change of Offset at 12months from 6months in two groups
Time Frame: 12 months
|
12 months
|
|
Constant-Murly scores at 3 months, 12 months and last follow-up
Time Frame: 3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )
|
3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )
|
|
change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 3, 2017
Study Registration Dates
First Submitted
January 12, 2017
First Submitted That Met QC Criteria
January 13, 2017
First Posted (Estimate)
January 18, 2017
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 22, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZhouXuANFSNF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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