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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
Sponsor:
Collaborators:
Information provided by:

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".


Condition or disease Intervention/treatment Phase
Proximal Humeral Fracture Device: Locking proximal humerus plate Device: Proximal Humerus Internal Locking System Device: Proximal Humerus Nail Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Standard Treatment Methods for Proximal Humerus Fractures
Study Start Date : August 2002
Estimated Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Radiological comparison of the fracture healing
  2. Functional outcome based on "constant and neer score" after 12 months

Secondary Outcome Measures :
  1. Analysis of occured complications
  2. Radiological evaluation of possible misallocation
  3. Subjective patient judgement of before and after treatment according to DASH-questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00205959     History of Changes
Other Study ID Numbers: 02-LPP-04
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 7, 2006
Last Verified: September 2005

Keywords provided by AO Clinical Investigation and Documentation:
Humerus
Fractures
Locking Plates
Nail System

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries