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

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

Interventions

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.

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Johns Hopkins All Children's Hospital

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Birmingham Children's Hospital

  collaborator OTHER

• Morgan Stanley Children's Hospital

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Gillette Children's Specialty Healthcare

  collaborator OTHER

• Levine Children's Hospital

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital

  collaborator OTHER

• Medical University of South Carolina Shawn Jenkins Children's Hospital

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Primary Children's Hospital

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• The Children's Hospital at OU Medical Center

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• University of California

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Vermont

  collaborator OTHER

• UVA Children's Hospital

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• David D Limbrick, MD, PhD · Washington University-St. Louis Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2020-07-31

Completion

2020-07-31

Countries

• United States

Study Locations