NCT01667770

Dural Graft Equivalent Comparison Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chiari Malformation

Interventions

Type	Name	Description
PROCEDURE	decompression of Chiari malformation	Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).

Timeline

• Start date: 2012-01-18
• Primary completion: 2016-12-21
• Completion: 2018-03-12
• First posted: 2012-08-17
• Last updated: 2021-06-15

Locations

1 site across 1 country: United States