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Clinical Trials/NCT00205972
NCT00205972
Completed
Phase 4

Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

AO Clinical Investigation and Publishing Documentation1 site in 1 country300 target enrollmentDecember 2000

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Humerusshaft Fractures
Sponsor
AO Clinical Investigation and Publishing Documentation
Enrollment
300
Locations
1
Primary Endpoint
- Comparison of functional outcome
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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".

Detailed Description

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".

Registry
clinicaltrials.gov
Start Date
December 2000
End Date
October 2004
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

- Comparison of functional outcome

Time Frame: 3 months to 12 months post OP

Comparison of functional outcome

- Radiological comparison of fracture healing between the conservative versus operative treatment

Time Frame: 3 months to 12 months post OP

Radiological comparison of fracture healing between the conservative versus operative treatment

Secondary Outcomes

  • - Subject satisfaction(3 months to 12 months post OP)
  • - Collection of possible complication of the treatment(3 months to 12 months post OP)
  • - Financial impact of the compared treatments(3 months to 12 months post OP)

Study Sites (1)

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