Back to resultsPosterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Primary Purpose
Arnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterior fossa decompression
Dural Augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Arnold-Chiari Malformation, Type 1
Eligibility Criteria
Inclusion Criteria:
- Age ≤21 years old
- Chiari malformation type I ≥5 mm tonsillar ectopia
- Syrinx between 3 mm and 6 mm
- Chiari Severity Index (CSI) classification 1
- MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
Exclusion Criteria:
- CSI-2 or CSI-3 classification
- Syrinx <3 mm and/or ≥6 mm
- Neuro-imaging demonstrating basilar invagination
- Clival canal angle <120° (signs of severe craniovertebral junction disease)
- Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
- Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
- Patients who do not wish to participate
Sites / Locations
- St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Posterior fossa decompression surgery
Dural augmentation surgery
Arm Description
The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed.
Outcomes
Primary Outcome Measures
The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.
The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.
Secondary Outcome Measures
Compare the change in size of syrinx before and after decompression.
Syrinx size will be measured with radiographic imaging pre-operatively and 12 months post-operatively.
Full Information
NCT ID
NCT02669836
First Posted
January 13, 2016
Last Updated
August 10, 2020
Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, Johns Hopkins All Children's Hospital, Arkansas Children's Hospital Research Institute, Boston Children's Hospital, Children's Healthcare of Atlanta, Dartmouth-Hitchcock Medical Center, Children's Hospital Colorado, Birmingham Children's Hospital, Children's Hospital of New York-Presbyterian, Children's Hospital of Phoenix, Children's Hospital and Health System Foundation, Wisconsin, Children's National Research Institute, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Gillette Children's Specialty Healthcare, Levine Children's Hospital, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Mayo Clinic, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, MUSC Children's Hospital, Oregon Health and Science University, Penn State University, University of Pittsburgh, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, Baylor College of Medicine, The Children's Hospital at OU Medical Center, Nationwide Children's Hospital, University of California, University of Iowa, University of Michigan, The University of Texas Health Science Center, Houston, University of Minnesota, University of Vermont Children's Hospital, UVA Children's Hospital, University of Wisconsin, Madison, Vanderbilt University, Wake Forest University, Yale University
1. Study Identification
Unique Protocol Identification Number
NCT02669836
Brief Title
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Official Title
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, Johns Hopkins All Children's Hospital, Arkansas Children's Hospital Research Institute, Boston Children's Hospital, Children's Healthcare of Atlanta, Dartmouth-Hitchcock Medical Center, Children's Hospital Colorado, Birmingham Children's Hospital, Children's Hospital of New York-Presbyterian, Children's Hospital of Phoenix, Children's Hospital and Health System Foundation, Wisconsin, Children's National Research Institute, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Gillette Children's Specialty Healthcare, Levine Children's Hospital, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Mayo Clinic, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, MUSC Children's Hospital, Oregon Health and Science University, Penn State University, University of Pittsburgh, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, Baylor College of Medicine, The Children's Hospital at OU Medical Center, Nationwide Children's Hospital, University of California, University of Iowa, University of Michigan, The University of Texas Health Science Center, Houston, University of Minnesota, University of Vermont Children's Hospital, UVA Children's Hospital, University of Wisconsin, Madison, Vanderbilt University, Wake Forest University, Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.
Detailed Description
Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: < 6 weeks, 3-6 months, and 12 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. A brain and cervical spine MRI will be performed 12 months after the decompression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation, Syringomyelia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior fossa decompression surgery
Arm Type
Experimental
Arm Description
The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected
Arm Title
Dural augmentation surgery
Arm Type
Experimental
Arm Description
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed.
Intervention Type
Procedure
Intervention Name(s)
Posterior fossa decompression
Other Intervention Name(s)
Bone only posterior decompression, Extradural posterior decompression
Intervention Description
Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected.
Intervention Type
Procedure
Intervention Name(s)
Dural Augmentation
Intervention Description
The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft.
Primary Outcome Measure Information:
Title
The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.
Time Frame
6 months from decompression
Title
The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.
Time Frame
12 months from decompression
Secondary Outcome Measure Information:
Title
Compare the change in size of syrinx before and after decompression.
Description
Syrinx size will be measured with radiographic imaging pre-operatively and 12 months post-operatively.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change of quality of life using Children Health Index Pediatrics (CHIP) questionnaire.
Time Frame
6 weeks from decompression
Title
Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire.
Time Frame
6 months from decompression
Title
Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire.
Time Frame
12 months from decompression
Title
Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.
Time Frame
6 weeks from decompression
Title
Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.
Time Frame
6 months from decompression
Title
Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.
Time Frame
12 months from decompression
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≤21 years old
Chiari malformation type I ≥5 mm tonsillar ectopia
Syrinx between 3 mm and 6 mm
Chiari Severity Index (CSI) classification 1
MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
Exclusion Criteria:
CSI-2 or CSI-3 classification
Syrinx <3 mm and/or ≥6 mm
Neuro-imaging demonstrating basilar invagination
Clival canal angle <120° (signs of severe craniovertebral junction disease)
Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
Patients who do not wish to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D Limbrick, MD, PhD
Organizational Affiliation
Washington University-St. Louis Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
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