Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
NCT ID: NCT02669836
Last Updated: 2024-10-31
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
162 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-30
Study Completion Date
2020-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Arnold-Chiari Malformation, Type 1
Chiari Malformation Type I
Type I Arnold-Chiari Malformation
Syringomyelia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Posterior fossa decompression surgery
The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected
Group Type
EXPERIMENTAL
Posterior fossa decompression
Intervention Type
PROCEDURE
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.
Dural augmentation surgery
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.
Group Type
EXPERIMENTAL
Dural Augmentation
Intervention Type
PROCEDURE
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.
Interventions
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Posterior fossa decompression
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
Dural Augmentation
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.
Intervention Type
PROCEDURE
Other Intervention Names
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Bone only posterior decompression
Extradural posterior decompression
Eligibility Criteria
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Inclusion Criteria
1. Age ≤21 years old
2. Chiari malformation type I ≥5 mm tonsillar ectopia
3. Syrinx between 3 mm and 6 mm
4. Chiari Severity Index (CSI) classification 1
5. 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
2. Chiari malformation type I ≥5 mm tonsillar ectopia
3. Syrinx between 3 mm and 6 mm
4. Chiari Severity Index (CSI) classification 1
5. 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
1. CSI-2 or CSI-3 classification
2. Syrinx \<3 mm and/or ≥6 mm
3. Neuro-imaging demonstrating basilar invagination
4. Clival canal angle \<120° (signs of severe craniovertebral junction disease)
5. Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
6. Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
7. Patients who do not wish to participate
2. Syrinx \<3 mm and/or ≥6 mm
3. Neuro-imaging demonstrating basilar invagination
4. Clival canal angle \<120° (signs of severe craniovertebral junction disease)
5. Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
6. Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
7. Patients who do not wish to participate
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
Johns Hopkins All Children's Hospital
OTHER
Sponsor Role
collaborator
Arkansas Children's Hospital Research Institute
OTHER
Sponsor Role
collaborator
Boston Children's Hospital
OTHER
Sponsor Role
collaborator
Children's Healthcare of Atlanta
OTHER
Sponsor Role
collaborator
Dartmouth-Hitchcock Medical Center
OTHER
Sponsor Role
collaborator
Children's Hospital Colorado
OTHER
Sponsor Role
collaborator
Birmingham Children's Hospital
OTHER
Sponsor Role
collaborator
Morgan Stanley Children's Hospital
OTHER
Sponsor Role
collaborator
Phoenix Children's Hospital
OTHER
Sponsor Role
collaborator
Children's Hospital and Health System Foundation, Wisconsin
OTHER
Sponsor Role
collaborator
Children's National Research Institute
OTHER
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
collaborator
Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
collaborator
Gillette Children's Specialty Healthcare
OTHER
Sponsor Role
collaborator
Levine Children's Hospital
OTHER
Sponsor Role
collaborator
Children's Hospital Los Angeles
OTHER
Sponsor Role
collaborator
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Sponsor Role
collaborator
Mayo Clinic
OTHER
Sponsor Role
collaborator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
OTHER
Sponsor Role
collaborator
Medical University of South Carolina Shawn Jenkins Children's Hospital
OTHER
Sponsor Role
collaborator
Oregon Health and Science University
OTHER
Sponsor Role
collaborator
Penn State University
OTHER
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
collaborator
Primary Children's Hospital
OTHER
Sponsor Role
collaborator
Seattle Children's Hospital
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Baylor College of Medicine
OTHER
Sponsor Role
collaborator
The Children's Hospital at OU Medical Center
OTHER
Sponsor Role
collaborator
Nationwide Children's Hospital
OTHER
Sponsor Role
collaborator
University of California
OTHER
Sponsor Role
collaborator
University of Iowa
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
The University of Texas Health Science Center, Houston
OTHER
Sponsor Role
collaborator
University of Minnesota
OTHER
Sponsor Role
collaborator
University of Vermont
OTHER
Sponsor Role
collaborator
UVA Children's Hospital
OTHER
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
collaborator
Vanderbilt University
OTHER
Sponsor Role
collaborator
Wake Forest University
OTHER
Sponsor Role
collaborator
Yale University
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David D Limbrick, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University-St. Louis Children's Hospital
Locations
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St. Louis Children's Hospital
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Hale AT, Adelson PD, Albert GW, Aldana PR, Alden TD, Anderson RCE, Bauer DF, Bonfield CM, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Durham SR, Ellenbogen RG, Eskandari R, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Johnston JM, Keating RF, Leonard JR, Maher CO, Mangano FT, McComb JG, Meehan T, Menezes AH, O'Neill B, Olavarria G, Park TS, Ragheb J, Selden NR, Shah MN, Smyth MD, Stone SSD, Strahle JM, Wait SD, Wellons JC, Whitehead WE, Shannon CN, Limbrick DD; Park-Reeves Syringomyelia Research Consortium Investigators. Factors associated with syrinx size in pediatric patients treated for Chiari malformation type I and syringomyelia: a study from the Park-Reeves Syringomyelia Research Consortium. J Neurosurg Pediatr. 2020 Mar 6;25(6):629-639. doi: 10.3171/2020.1.PEDS19493. Print 2020 Jun 1.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCORI275- 201604044
Identifier Type: -
Identifier Source: org_study_id
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