Management of Bone Defects Around the Elbow

April 14, 2015 updated by: Medical University of Vienna

Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type of prosthesis:

STRYKER Humerus-HMRS

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

  • Unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients with major bone defects around the elbow.
Procedure: HMRS
Modular prosthetic replacement of the humerus and elbow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Survival
Time Frame: 20 Years
20 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Prosthetic Survival
Time Frame: 20 Years
20 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • funovics1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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