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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

September 13, 2005
September 6, 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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
640
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00205959
02-LPP-04
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