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OpenTrials
Completed

NCT Number: NCT00205959

LPHP-Philos-PHN Conservative Treatment

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".

Completed

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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitaestklinik Freiburg, Klinik für Traumatologie

Freiburg im Breisgau, 79106, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locking proximal humerus plate

Device

Proximal Humerus Internal Locking System

Device

Proximal Humerus Nail

Device

Primary outcomes

  1. Radiological comparison of the fracture healing

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

Secondary outcomes

  1. Analysis of occured complications

  2. Radiological evaluation of possible misallocation

  3. Subjective patient judgement of before and after treatment according to DASH-questionnaire

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AO Research Fund
  • Synthes Inc.

Registry information

Official study title

Comparison of Standard Treatment Methods for Proximal Humerus Fractures

Important dates

Study start
2002
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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