Management of Bone Defects Around the Elbow

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00873145
First received: March 31, 2009
Last updated: January 19, 2010
Last verified: March 2009
  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.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Patient Survival [ Time Frame: 20 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prosthetic Survival [ Time Frame: 20 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873145

Contacts
Contact: Philipp T Funovics, MD +43140400 ext 4082 philipp.funovics@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Department of Orthopaedics Recruiting
Vienna, Austria, 1090
Contact: Philipp T Funovics, MD    +43140400 ext 4082    philipp.funovics@meduniwien.ac.at   
Principal Investigator: Philipp T Funovics, MD         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Philipp T. Funovics, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00873145     History of Changes
Other Study ID Numbers: funovics1
Study First Received: March 31, 2009
Last Updated: January 19, 2010
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on October 19, 2014