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Completed

NCT Number: NCT02669836

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

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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Key information

Conditions

Arnold-Chiari Malformation, Type 1 Arnold-Chiari Malformation Central Nervous System Diseases Chiari Malformation Type I Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Cord Diseases Syringomyelia Type I Arnold-Chiari Malformation

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Bone only posterior decompression, Extradural posterior decompression

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.

Primary outcomes

  1. The Number of Participants With Surgical Complications

    Time frame: less then or equal to 6 months from decompression

    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

Secondary outcomes

  1. Aim 2: The Number of Patients With Clinical Improvement

    Time frame: 10-14 months

    Number of patients who experienced improvement in clinical or neurological symptoms-such as; headaches, pain, numbness or tingling, nausea/ vomiting, itching, weakness, difficulty swallowing, difficulty sleeping and cranial nerve assessments.

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

    Time frame: 10-14 months

    Syrinx regression comparison between posterior fossa decompression surgery and dural augmentation surgery cohorts based on ITT.

Other outcomes

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

    Time frame: 10-14 Months from Decompression

    Quality of Life (QOL) was assessed using the Chiari Health Index Pediatrics (CHIP), and the Health Utilities-3 (HUI-3). The CHIP is a 5-point response scale. Within the physical symptoms' domain, 5 questions regarding pain severity are alternatively scaled.

    The Health Utilities Index Mark 3 (HUI3) is a generic status classification system, generalizable in pediatric patients with illness. The HUI3 assesses domains including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain.

    We used a non-inferiority approach in the analysis. The score is corrected for missing values and scaled to a range of scores between 0 and 1. An increasing score represents increasing HRQOL. Increase/decrease in the quality of life metric (on a scale from 0-1, with 0 representing no quality of life and 1 representing 100% quality of life).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2016
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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