Text Size

LPHP-Philos-PHN Conservative Treatment

This study has been completed.
Sponsor:
Collaborators:
Synthes Inc.
AO Research Fund
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00205959
First received: September 13, 2005
Last updated: September 6, 2006
Last verified: September 2005
History of Changes
  Purpose

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".


Condition Intervention Phase
Proximal Humeral Fracture
 Device: Locking proximal humerus plate
Device: Proximal Humerus Internal Locking System
Device: Proximal Humerus Nail
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Standard Treatment Methods for Proximal Humerus Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Radiological comparison of the fracture healing
  • Functional outcome based on "constant and neer score" after 12 months

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

Estimated Enrollment: 640
Study Start Date: August 2002
Estimated Study Completion Date: August 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205959

Locations
Germany
Universitaestklinik Freiburg, Klinik für Traumatologie
Freiburg, Germany, 79106
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
AO Research Fund
Investigators
Principal Investigator: Norbert Südkamp, Prof. MD Universitaetsklinik Freiburg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00205959     History of Changes
Other Study ID Numbers: 02-LPP-04
Study First Received: September 13, 2005
Last Updated: September 6, 2006
Health Authority: Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:
Humerus
Fractures
Locking Plates
Nail System

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 23, 2013