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Non Randomized Humerusshaft Fracture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205972
First Posted: September 21, 2005
Last Update Posted: November 20, 2007
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.
Collaborator:
AOAA Switzerland
Information provided by:
AO Clinical Investigation and Documentation
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00205972     History of Changes
Other Study ID Numbers: 00-NRH-04
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 20, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries