Chiari Study Looking at Use of Duragen Versus Duraguard

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.

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.

Subjects diagnosed with symptomatic Chiari I Malformation

Inclusion Criteria:

1. Age >18 years
2. Clinical Diagnosis of Chiari Type I Malformation
3. Radiogrpahic evidence of downward tonsillar herniation (displacement of the lower part of the cerebellum below the level of the skull)
4. Signed Written Informed Consent

Exclusion Criteria:

1. Presence of Hydrocephalus or previous CSF diversion procedure, such as shunt
2. Prior operation on the posterior cranial fossa
3. Inability to understand the informed consent or unwillingness to participate in the study
4. Inability to return for follow-up evaluation 3 months after the surgery
5. Evidence of spinal dysraphism
6. Allergy or history of allergic reaction to Duragen, Duraguard, or their components
7. Pregnancy as documented by a urine or blood test