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Clinical Trials/NCT00205959
NCT00205959CompletedPhase 4

Comparison of Standard Treatment Methods for Proximal Humerus Fractures

AO Clinical Investigation and Publishing Documentation2 sites in 1 country640 target enrollmentStarted: August 1, 2002Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
640
Locations
2
Primary Endpoint
Functional outcome based on "constant and neer score" after 12 months
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation
Sponsor Class
Other

Study Sites (2)

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