ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02669836
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : March 15, 2018
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
Children’s Hospital of Birmingham
Children’s Hospital of New York-Presbyterian
Children’s Hospital of Phoenix
Children's Hospital and Health System Foundation, Wisconsin
Children's Research Institute
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Columbia University
Gillette Children’s Hospital Minnesota
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
Texas Children's Hospital
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 - Clinical and Translational Science Institute
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syringomyelia

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.




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 ]


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.


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

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


Contacts
Contact: David D Limbrick, MD, PhD (314) 454-4454 LimbrickD1@wudosis.wustl.edu
Contact: Catharine Richard, BSN RN (314) 454-3212 richardc@wudosis.wustl.edu

Locations
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David Limbrick, M.D., PhD.    314-454-4454    limbrickD1@wudosis.wustl.edu   
Contact: Catharine Richard, BSN RN    314-454-3212    richardc@wudosis.wustl.edu   
Principal Investigator: David Limbrick, M.D., PhD.         
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
Children’s Hospital of Birmingham
Children’s Hospital of New York-Presbyterian
Children’s Hospital of Phoenix
Children's Hospital and Health System Foundation, Wisconsin
Children's Research Institute
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Columbia University
Gillette Children’s Hospital Minnesota
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
Texas Children's Hospital
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 - Clinical and Translational Science Institute
University of Vermont Children’s Hospital
UVA Children’s Hospital
University of Wisconsin, Madison
Vanderbilt University
Wake Forest University
Yale University
Investigators
Principal Investigator: David D Limbrick, MD, PhD Washington University-St. Louis Children's Hospital

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.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02669836     History of Changes
Other Study ID Numbers: PCORI275
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Congenital Abnormalities
Syringomyelia
Arnold-Chiari Malformation
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations