Dural Graft Equivalent Comparison Trial

Not Applicable

Completed

• Conditions: Chiari Malformation
• Interventions: Procedure: decompression of Chiari malformation

• Registration Number: NCT01667770
• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

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.

Study Timeline

• Study Start: 2012-01-18
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2016-12-21
• Study Completion: 2018-03-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery - non-autologous graft	decompression of Chiari malformation	surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
surgery - autologous graft	decompression of Chiari malformation	surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft

Primary Outcome Measures

Name	Time	Method
Complications encountered during the subject's post-operative care	2 years	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.

Trial Locations

Locations (1)

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States