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Non Randomized Humerusshaft Fracture

This study has been completed.
Sponsor:
Collaborator:
AOAA Switzerland
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00205972
First received: September 13, 2005
Last updated: November 19, 2007
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013