Dural Graft Equivalent Comparison Trial

NCT ID: NCT01667770

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-18
• Study Completion Date: 2018-03-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

surgery - autologous graft

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

Group Type: ACTIVE_COMPARATOR

decompression of Chiari malformation

Intervention Type: PROCEDURE

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).

surgery - non-autologous graft

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

Group Type: ACTIVE_COMPARATOR

decompression of Chiari malformation

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F Spetzler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurosurgical Associates

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

11BN113

Identifier Type: -

Identifier Source: org_study_id