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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
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Humerus, Fractures, Locking Plates, Nail System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
August 12, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Research Fund
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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

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LPHP-Philos-PHN Conservative Treatment

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