Dural Graft Equivalent Comparison Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dural Graft Equivalent Comparison Trial

Conditions
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Chiari Malformation

Intervention / Treatment
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* Procedure: decompression of Chiari malformation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery - autologous graft<br>surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft | Procedure: decompression of Chiari malformation<br>* 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).<br>|
| Active Comparator: surgery - non-autologous graft<br>surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft | Procedure: decompression of Chiari malformation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications encountered during the subject's post-operative care | 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. | 2 years |