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Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669836
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : August 11, 2020
Sponsor:
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
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arnold-Chiari Malformation, Type 1 Chiari Malformation Type I Type I Arnold-Chiari Malformation Syringomyelia Procedure: Posterior fossa decompression Procedure: Dural Augmentation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Procedure: 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.
Other Names:
  • Bone only posterior decompression
  • Extradural posterior decompression
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Compare the change in size of syrinx before and after decompression. [ Time Frame: 12 months ]
    Syrinx size will be measured with radiographic imaging pre-operatively and 12 months post-operatively.


Other Outcome Measures:
  1. Change of quality of life using Children Health Index Pediatrics (CHIP) questionnaire. [ Time Frame: 6 weeks from decompression ]
  2. Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire. [ Time Frame: 6 months from decompression ]
  3. Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire. [ Time Frame: 12 months from decompression ]
  4. Change of quality of life using Health Utilities 3 (HUI-3) questionnaire. [ Time Frame: 6 weeks from decompression ]
  5. Change of quality of life using Health Utilities 3 (HUI-3) questionnaire. [ Time Frame: 6 months from decompression ]
  6. Change of quality of life using Health Utilities 3 (HUI-3) questionnaire. [ Time Frame: 12 months from decompression ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669836


Locations
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United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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
Investigators
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Principal Investigator: David D Limbrick, MD, PhD Washington University-St. Louis Children's Hospital
More Information
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Publications:
Wellons JC & Smyth MD (2013) Neurosurgical Face Off: Durotomy and Duraplasty Versus No Durotomy and Duraplasty. Annual Scientific Meeting of the American Association of Neurological Surgeons.
Carmines EG & Zeller RA (1979) Reliability and Validity Assessment. Quatitative Applications in the Social Sciences. (Sage Publications, Newbury Park, CA).
Donner A & Klar N (2000) Design and Analysis of Cluster Randomization Trials in Health Research (Arnold; Oxford University Press, New York).
Little RJA & Rubin DB (2002) Statistical Analysis With Missing Data (Wiley, Hoboken, N.J.) Second Edition Ed.
Buck SF (1960) A method of estimation of missing values in multivariate data suitable for use with an electronic computer. J Roy Statist Soc 22:302-306.
Greenberg JK, et al. (2014) Population-Based Analysis of Complications Associated with Chiari Malformation Type 1 Surgery in Children. AANS/CNS Joint Section on Pediatric Neurosurgery.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 6:1-11. doi: 10.3171/2020.1.PEDS19493. Online ahead of print.

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02669836    
Other Study ID Numbers: PCORI275- 201604044
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Arnold-Chiari Malformation
Syringomyelia
Congenital Abnormalities
Neural Tube Defects
 Nervous System Malformations
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases