Dural Graft Equivalent Comparison Trial (DECOMPRESS)

St. Joseph's Hospital and Medical Center, Phoenix

Status: Completed

Conditions: Chiari Malformation

Treatments: Procedure: decompression of Chiari malformation

Study type: Interventional

Funder types: Other

Identifiers

NCT01667770

11BN113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

surgery - autologous graft

Active Comparator group

Description:

surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft

Treatment:

Procedure: decompression of Chiari malformation

surgery - non-autologous graft

Active Comparator group

Description:

surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft

Treatment:

Procedure: decompression of Chiari malformation