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Non Randomized Humerusshaft Fracture

This study has been completed.

Sponsors and Collaborators: AO Clinical Investigation and Documentation
AOAA Switzerland
Information provided by: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00205972
  Purpose

The aim of the study is to radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".


Condition Intervention Phase
Humerusshaft Fractures
 Device: Humerus Nail or LC Plate
 Phase IV

MedlinePlus related topics:   Fractures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

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

Primary Outcome Measures:
  • - Radiological comparison of fracture healing between the conservative versus operative treatment
  • - Comparison of functional outcome

Secondary Outcome Measures:
  • - Collection of possible complication of the treatment
  • - Subject satisfaction
  • - Financial impact of the compared treatments

Estimated Enrollment:   300
Study Start Date:   December 2000
Estimated Study Completion Date:   October 2004

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • over age 16
  • fracture according to AO classifications 12A2, 12A3, 12B2
  • have to be available for the FU's

Exclusion Criteria:

  • open fractures
  • polytraumatized patients
  • multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
  • pseudoarthrosis
  • pathological and refractures
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205972

Locations
Switzerland
Spital Uster    
      Uster, Switzerland, 8610

Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOAA Switzerland

Investigators
Principal Investigator:     Gian Melcher, PD MD     Spital Uster    
  More Information


Study ID Numbers:   00-NRH-04, --
First Received:   September 13, 2005
Last Updated:   November 19, 2007
ClinicalTrials.gov Identifier:   NCT00205972
Health Authority:   Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:
Fractures  
Humerus  
Conservative treatment  
Operative treatment  

Study placed in the following topic categories:
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 16, 2008

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