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

NCT02669836 | Completed Results DMC

• 1 other identifier: PCORI275- 201604044
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Arnold-Chiari Malformation, Type 1; Chiari Malformation Type I; Type I Arnold-Chiari Malformation; Syringomyelia

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Surgical Complications

  The number of participants with complications such as: Cerebrospinal fluid (CSF)-related complications ≤6 months (e.g. CSF leak, pseudomeningocele, aseptic meningitis, infection, hydrocephalus), and the requirement for additional surgery for wound revision or CSF diversion

  less then or equal to 6 months from decompression

Secondary Outcomes (2)

• Aim 2: The Number of Patients With Clinical Improvement

  10-14 months

• Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.

  10-14 months

Other Outcomes (1)

• Aim 3 : Mean Change in Quality of Life Measurement After Surgery Relative to Baseline.

  10-14 Months from Decompression

Study Arms (2)

Posterior fossa decompression surgery

EXPERIMENTAL

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

Dural augmentation surgery

EXPERIMENTAL

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

Interventions

Posterior fossa decompression 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.

Also known as: Bone only posterior decompression, Extradural posterior decompression

Posterior fossa decompression surgery

Dural Augmentation 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.

Dural augmentation surgery

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Johns Hopkins All Children's Hospital: collaborator
• Arkansas Children's Hospital Research Institute: collaborator
• Boston Children's Hospital: collaborator
• Children's Healthcare of Atlanta: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Children's Hospital Colorado: collaborator
• Birmingham Children's Hospital: collaborator
• Morgan Stanley Children's Hospital: collaborator
• Phoenix Children's Hospital: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• Children's National Research Institute: collaborator
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Columbia University: collaborator
• Gillette Children's Specialty Healthcare: collaborator
• Levine Children's Hospital: collaborator
• Children's Hospital Los Angeles: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Mayo Clinic: collaborator
• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: collaborator
• Medical University of South Carolina Shawn Jenkins Children's Hospital: collaborator
• Oregon Health and Science University: collaborator
• Penn State University: collaborator
• University of Pittsburgh: collaborator
• Primary Children's Hospital: collaborator
• Seattle Children's Hospital: collaborator
• Stanford University: collaborator
• Baylor College of Medicine: collaborator
• The Children's Hospital at OU Medical Center: collaborator
• Nationwide Children's Hospital: collaborator
• University of California: collaborator
• University of Iowa: collaborator
• University of Michigan: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• University of Minnesota: collaborator
• University of Vermont: collaborator
• UVA Children's Hospital: collaborator
• University of Wisconsin, Madison: collaborator
• Vanderbilt University: collaborator
• Wake Forest University: collaborator
• Yale University: collaborator

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (44)

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MeSH Terms

Conditions

Arnold-Chiari Malformation; Syringomyelia

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: David D. Limbrick MD
• Organization: Washington University

T.Meehan@wustl.edu

314-454-3212

Study Officials

• David D Limbrick, MD, PhD

  Washington University-St. Louis Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: February 1, 2016
• Study Start: April 1, 2016
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-08

Locations

US (1)