LPHP-Philos-PHN Conservative Treatment - Full Text View

Purpose

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".

Condition	Intervention	Phase
Proximal Humeral Fracture	Device: Locking proximal humerus plate Device: Proximal Humerus Internal Locking System Device: Proximal Humerus Nail	Phase IV

MedlinePlus related topics:

Fractures Shoulder Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Comparison of Standard Treatment Methods for Proximal Humerus Fractures

Further study details as provided by AO Clinical Investigation and Documentation:

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

Estimated Enrollment:	640
Study Start Date:	August 2002
Estimated Study Completion Date:	August 2006

Detailed Description:

Evaluation of proximal humeral fractures using a new stable-angled implant.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205959

Locations


Germany
	Universitaestklinik Freiburg, Klinik für Traumatologie
	Freiburg, Germany, 79106

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Synthes Inc.

AO Research Fund

Investigators


Principal Investigator:	Norbert Südkamp, Prof. MD	Universitaetsklinik Freiburg

More Information

Study ID Numbers:	02-LPP-04
First Received:	September 13, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00205959
Health Authority:	Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:

Humerus

Fractures

Locking Plates

Nail System

Study placed in the following topic categories:

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

Humeral Fractures

Arm Injuries

Shoulder Fractures

ClinicalTrials.gov processed this record on October 16, 2008

Sponsors and Collaborators:	AO Clinical Investigation and Documentation Synthes Inc. AO Research Fund
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00205959