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LPHP-Philos-PHN Conservative Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205959
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 7, 2006
Information provided by:

September 13, 2005
September 21, 2005
September 7, 2006
August 2002
Not Provided
  • Radiological comparison of the fracture healing
  • Functional outcome based on "constant and neer score" after 12 months
  • - Radiological comparison of the fracture healing
  • - Functional outcome based on "constant and neer score" after 12 months
Complete list of historical versions of study NCT00205959 on ClinicalTrials.gov Archive Site
  • Analysis of occured complications
  • Radiological evaluation of possible misallocation
  • Subjective patient judgement of before and after treatment according to DASH-questionnaire
  • - analysis of occured complications
  • - radiological evaluation of possible missallocation
  • - subjective patient judgement of before and after treatment according to DASH-questionaire
Not Provided
Not Provided
LPHP-Philos-PHN Conservative Treatment
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".

Evaluation of proximal humeral fractures using a new stable-angled implant.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Proximal Humeral Fracture
  • Device: Locking proximal humerus plate
  • Device: Proximal Humerus Internal Locking System
  • Device: Proximal Humerus Nail
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
AO Clinical Investigation and Documentation
  • Synthes Inc.
  • AO Research Fund
Principal Investigator: Norbert Südkamp, Prof. MD Universitaetsklinik Freiburg
AO Clinical Investigation and Documentation
September 2005

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