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Clinical Trials/NCT00205959
NCT00205959
Completed
Phase 4

Comparison of Standard Treatment Methods for Proximal Humerus Fractures

AO Clinical Investigation and Publishing Documentation1 site in 1 country640 target enrollmentAugust 2002
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ConditionsProximal Humeral Fracture

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Proximal Humeral Fracture
Sponsor
AO Clinical Investigation and Publishing Documentation
Enrollment
640
Locations
1
Primary Endpoint
Functional outcome based on "constant and neer score" after 12 months
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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".

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
August 2002
End Date
August 2006
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation

Eligibility 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

Outcomes

Primary Outcomes

Functional outcome based on "constant and neer score" after 12 months

Radiological comparison of the fracture healing

Secondary Outcomes

  • Analysis of occured complications
  • Subjective patient judgement of before and after treatment according to DASH-questionnaire
  • Radiological evaluation of possible misallocation

Study Sites (1)

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