Management of Bone Defects Around the Elbow

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873145
• Other study ID #: funovics1
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: April 14, 2015
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Description:

Type of prosthesis:

STRYKER Humerus-HMRS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

• Unwillingness to participate

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer
• Fracture
• Tumor

Intervention

Procedure:
• HMRS
Modular prosthetic replacement of the humerus and elbow.

Locations

Country	Name	City	State
Austria	Medical University of Vienna Department of Orthopaedics	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival		20 Years	No
Secondary	Prosthetic Survival		20 Years	No