LPHP-Philos-PHN Conservative Treatment

This study has been completed.

Sponsor:

Collaborators:

Synthes Inc.

AO Research Fund

Information provided by:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier:

NCT00205959

First received: September 13, 2005

Last updated: September 6, 2006

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 6, 2006

Start Date ^ICMJE

August 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Radiological comparison of the fracture healing
Functional outcome based on "constant and neer score" after 12 months

Original Primary Outcome Measures ^ICMJE

- Radiological comparison of the fracture healing
- Functional outcome based on "constant and neer score" after 12 months

Change History

Complete list of historical versions of study NCT00205959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analysis of occured complications
Radiological evaluation of possible misallocation
Subjective patient judgement of before and after treatment according to DASH-questionnaire

Original Secondary Outcome Measures ^ICMJE

- analysis of occured complications
- radiological evaluation of possible missallocation
- subjective patient judgement of before and after treatment according to DASH-questionaire

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LPHP-Philos-PHN Conservative Treatment

Official Title ^ICMJE

Comparison of Standard Treatment Methods for Proximal Humerus Fractures

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Proximal Humeral Fracture

Intervention ^ICMJE

Device: Locking proximal humerus plate
Device: Proximal Humerus Internal Locking System
Device: Proximal Humerus Nail

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

640

Completion Date

August 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00205959

Other Study ID Numbers ^ICMJE

02-LPP-04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AO Clinical Investigation and Documentation

Collaborators ^ICMJE

Synthes Inc.
AO Research Fund

Investigators ^ICMJE

Principal Investigator:

Norbert Südkamp, Prof. MD

Universitaetsklinik Freiburg

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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