Dural Graft Equivalent Comparison Trial — DECOMPRESS  

Chiari Malformation Clinical Trial

Official title: Dural Graft Equivalent Comparison Trial

Status Completed

Clinical Trial Summary

This research study is to find out which types of dural grafts used during surgery for Chiari Malformations are superior. We believe that autologous dural grafts are superior to non-autologous grafts.

Clinical Trial Description

The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include synthetics and grafts from animals. Autologous grafts have a better side-effect profile than non-autologous grafts. We believe this improved side-effect profile will result in a decreased incidence of reoperation for post-operative infections and post-operative fluid collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and adult subjects. Subjects must have symptomatic Chiari Malformation described as > or equal to 6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient. ;

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation

• NCT number: NCT01667770
• Study type: Interventional
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Status: Completed
• Phase: N/A
• Start date: January 18, 2012
• Completion date: March 12, 2018