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Management of Bone Defects Around the Elbow

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873145
First Posted: April 1, 2009
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

Background:

Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.


Condition Intervention
Tumor Fracture Cancer Procedure: HMRS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Patient Survival [ Time Frame: 20 Years ]

Secondary Outcome Measures:
  • Prosthetic Survival [ Time Frame: 20 Years ]

Estimated Enrollment: 50
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with major bone defects around the elbow.
Procedure: HMRS
Modular prosthetic replacement of the humerus and elbow.

Detailed Description:

Type of prosthesis:

STRYKER Humerus-HMRS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with major bone defects around the elbow and/or distal humerus due to cancer or failed arthroplasty.
Criteria

Inclusion Criteria:

  • HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

  • Unwillingness to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873145


Locations
Austria
Medical University of Vienna Department of Orthopaedics
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

Responsible Party: Dr. Philipp T. Funovics, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00873145     History of Changes
Other Study ID Numbers: funovics1
First Submitted: March 31, 2009
First Posted: April 1, 2009
Last Update Posted: April 15, 2015
Last Verified: March 2009

Keywords provided by Medical University of Vienna:
Survival
Function
Infection
Revision
Loosening