Dural Graft Equivalent Comparison Trial (DECOMPRESS)
Primary Purpose
Chiari Malformation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
decompression of Chiari malformation
Sponsored by
About this trial
This is an interventional treatment trial for Chiari Malformation
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
Sites / Locations
- St. Joseph's Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
surgery - autologous graft
surgery - non-autologous graft
Arm Description
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01667770
First Posted
August 14, 2012
Last Updated
June 11, 2021
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
1. Study Identification
Unique Protocol Identification Number
NCT01667770
Brief Title
Dural Graft Equivalent Comparison Trial
Acronym
DECOMPRESS
Official Title
Dural Graft Equivalent Comparison Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2012 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
March 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chiari Malformation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery - autologous graft
Arm Type
Active Comparator
Arm Description
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
Arm Title
surgery - non-autologous graft
Arm Type
Active Comparator
Arm Description
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
Intervention Type
Procedure
Intervention Name(s)
decompression of Chiari malformation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Complications encountered during the subject's post-operative care
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Spetzler, M.D.
Organizational Affiliation
Barrow Neurosurgical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dural Graft Equivalent Comparison Trial
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