LPHP-Philos-PHN Conservative Treatment
August 12, 2020 updated by: AO Clinical Investigation and Publishing Documentation
Comparison of Standard Treatment Methods for Proximal Humerus Fractures
The aim of the study is to compare the results regarding fracture healing
and functional outcome after the treatment of proximal humeral fractures
with the four different treatment methods after 12w./6months and 12 months
based on radiological evaluation as well as the "constant score" and the
"neer score".
Study Overview
Status
Completed
Conditions
Detailed Description
Evaluation of proximal humeral fractures using a new stable-angled implant.
Study Type
Interventional
Enrollment
640
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Freiburg, Germany, 79106
- Universitaestklinik Freiburg, Klinik für Traumatologie
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- fractures of proximal humerus
- age over 18 years
- completed skeletal development
- fracture less than 5 days old
Exclusion Criteria:
- open fractures
- pseudoarthrosis, pathological or refractures
- ipsilateral fractures of distal humerus or elbow
- polytraumatic conditions
- pregnancy
- subject with known history of diseases that influence the healing process
- alcohol, drug abuse
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Radiological comparison of the fracture healing
|
|
Functional outcome based on "constant and neer score" after 12 months
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Analysis of occured complications
|
|
Radiological evaluation of possible misallocation
|
|
Subjective patient judgement of before and after treatment according to DASH-questionnaire
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Norbert Südkamp, Prof. MD, Universitaetsklinik Freiburg
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
August 1, 2002
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-LPP-04
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.