Chiari Study Looking at Use of Duragen Versus Duraguard

Chiari Malformation Type I Clinical Trial

Official title: Duragen vs. Duraguard in Chiari Surgery

Status Enrolling by invitation

Clinical Trial Summary

Since Chiari malformation is a common disease, many patients require surgical operation to relieve pressure from the back portion of the skull. The purpose of this research is to compare two different materials that are routinely used to repair the opening in the brain covering during the surgery on the back portion of the skull in patients with symptomatic Chiari Malformation. None of the materials used in this study nor any procedures are experimental.

Clinical Trial Description

Subjects are randomly assigned to receive either Duragen or Duraguard and then followed for a period of three months after surgery for follow-up evaluation as part of their routine care. The research portion of the study involves subjects completing a quality of life questionnaire each month and the research team reviews each subject's chart for any post-surgical complications. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation Type I
• Congenital Abnormalities

• NCT number: NCT00565435
• Study type: Observational
• Source: University of Illinois at Chicago
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2002
• Completion date: December 2008