Dural Graft Equivalent Comparison Trial

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.

Inclusion Criteria:

- Minor or adult males and females

- Symptomatic Chiari Malformation

- Greater or equal to 6mm descent of the cerebellar tonsils below the foramen magnum

- Headaches and/or neurologic findings (e.g., arm pain/weakness, myelopathy, etc.)

Exclusion Criteria:

- Pregnancy