LPHP-Philos-PHN Conservative Treatment

NCT ID: NCT00205959

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-08-31

Brief Summary

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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

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

Conditions

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Proximal Humeral Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Locking proximal humerus plate

Intervention Type DEVICE

Proximal Humerus Internal Locking System

Intervention Type DEVICE

Proximal Humerus Nail

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synthes Inc.

INDUSTRY

Sponsor Role collaborator

AO Research Fund

OTHER

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Principal Investigators

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Norbert Südkamp, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinik Freiburg

Locations

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Universitaestklinik Freiburg, Klinik für Traumatologie

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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02-LPP-04

Identifier Type: -

Identifier Source: org_study_id

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