LPHP-Philos-PHN Conservative Treatment
Primary Purpose
Proximal Humeral Fracture
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Locking proximal humerus plate
Proximal Humerus Internal Locking System
Proximal Humerus Nail
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Humerus, Fractures, Locking Plates, Nail System
Eligibility Criteria
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
Sites / Locations
- Universitaestklinik Freiburg, Klinik für Traumatologie
Outcomes
Primary Outcome Measures
Radiological comparison of the fracture healing
Functional outcome based on "constant and neer score" after 12 months
Secondary Outcome Measures
Analysis of occured complications
Radiological evaluation of possible misallocation
Subjective patient judgement of before and after treatment according to DASH-questionnaire
Full Information
NCT ID
NCT00205959
First Posted
September 13, 2005
Last Updated
August 12, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00205959
Brief Title
LPHP-Philos-PHN Conservative Treatment
Official Title
Comparison of Standard Treatment Methods for Proximal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Research Fund
4. Oversight
5. Study Description
Brief Summary
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".
Detailed Description
Evaluation of proximal humeral fractures using a new stable-angled implant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
Humerus, Fractures, Locking Plates, Nail System
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
640 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Locking proximal humerus plate
Intervention Type
Device
Intervention Name(s)
Proximal Humerus Internal Locking System
Intervention Type
Device
Intervention Name(s)
Proximal Humerus Nail
Primary Outcome Measure Information:
Title
Radiological comparison of the fracture healing
Title
Functional outcome based on "constant and neer score" after 12 months
Secondary Outcome Measure Information:
Title
Analysis of occured complications
Title
Radiological evaluation of possible misallocation
Title
Subjective patient judgement of before and after treatment according to DASH-questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Südkamp, Prof. MD
Organizational Affiliation
Universitaetsklinik Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaestklinik Freiburg, Klinik für Traumatologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
LPHP-Philos-PHN Conservative Treatment
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