Skip to main content
Patient-Centered Outcomes Research Institute
Patient-Centered Outcomes Research Institute
  • Blog
  • Newsroom
  • Find It Fast
  • Help Center
  • Subscribe
  • Careers
  • Contact Us

PCORI

Patient-Centered Outcomes Research Institute

Search form

  • About Us
    Close mega-menu

    About Us

    • Our Programs
    • Governance
    • Financials and Reports
    • Procurement Opportunities
    • Our Staff
    • Our Vision & Mission
    • Contact Us

    Fact Sheets: Learn More About PCORI

    Download fact sheets about out work, the research we fund, and our programs and initiatives.

    Find It Fast

    Browse through an alphabetical list of frequently accessed and searched terms for information and resources.

    Subscribe to PCORI Email Alerts

    Sign up for weekly emails to stay current on the latest results of our funded projects, and more.

  • Research & Results
    Close mega-menu

    Research & Results

    • Explore Our Portfolio
    • Research Fundamentals
    • Research Results Highlights
    • Putting Evidence to Work
    • Peer Review
    • Evidence Synthesis
    • About Our Research

    Evidence Updates from PCORI-Funded Studies

    These updates capture highlights of findings from systematic reviews and our funded research studies.

    Journal Articles About Our Funded Research

    Browse through a collection of journal publications that provides insights into PCORI-funded work.

    Explore Our Portfolio of Funded Projects

    Find out about projects based on the health conditions they focus on, the state they are in, and if they have results.

  • Topics
    Close mega-menu

    Topics

    • Addressing Disparities
    • Arthritis
    • Asthma
    • Cancer
    • Cardiovascular Disease
    • Children's Health
    • Community Health Workers
    • COVID-19
    • Dementia and Cognitive Impairment
    • Diabetes
    • Kidney Disease
    • Medicaid
    • Men's Health
    • Mental and Behavioral Health
    • Minority Mental Health
    • Multiple Chronic Conditions
    • Multiple Sclerosis
    • Obesity
    • Older Adults' Health
    • Pain Care and Opioids
    • Rare Diseases
    • Rural Health
    • Shared Decision Making
    • Telehealth
    • Transitional Care
    • Veterans Health
    • Women's Health

    Featured Topic: Women's Health

    Learn more about the projects we support on conditions that specifically or more often affect women.

  • Engagement
    Close mega-menu

    Engagement

    • The Value of Engagement
    • Engagement in Health Research Literature Explorer
    • Influencing the Culture of Research
    • Engagement Awards
    • Engagement Resources
    • Engage with Us

    Engagement Tools and Resources for Research

    This searchable peer-to-peer repository includes resources that can inform future work in patient-centered outcomes research.

    Explore Engagement in Health Literature

    This tool enables searching for published articles about engagement in health research.

    Research Fundamentals: A New On-Demand Training

    It enables those new to health research or patient-centered research to learn more about the research process.

  • Funding Opportunities
    Close mega-menu

    Funding Opportunities

    • What & Who We Fund
    • What You Need to Know to Apply
    • Applicant Training
    • Merit Review
    • Awardee Resources
    • Help Center

    PCORI Funding Opportunities

    View and learn about the newly opened funding announcements and the upcoming PFAs in 2021.

    Tips for Submitting a Responsive LOI

    Find out what PCORI looks for in a letter of intent (LOI) along with other helpful tips.

    PCORI Awardee Resources

    These resources can help awardees in complying with the terms and conditions of their contract.

  • Meetings & Events
    Close mega-menu

    Meetings & Events

    • Upcoming
    • Past Events

    January 2021 Board of Governors Meeting

    The Board approved funding for a new research study relating to kidney health and a new funding allocation for PCORnet. Learn more

    Confronting COVID-19: A Webinar Series

    Learn more about the series and access recordings and summary reports of all six sessions.

    2020 PCORI Annual Meeting

    Watch recordings of all sessions, and view titles and descriptions of the posters presented at the virtual meeting.

You are here

  • Research & Results
  • Explore Our Portfolio
  • Comparing Two Types of Surgery for Yo...

Comparing Two Types of Surgery for Young Patients with Chiari Type I Malformation and Syringomyelia

Sign Up for Updates to This Study  

Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Chiari type I malformation is a disorder where brain tissue extends into the spinal cord. Doctors usually diagnose this health problem in late childhood or early adulthood. Patients who have Chiari type I malformation and syringomyelia, a cyst or fluid-filled sac in the spinal cord, can have headaches and a hard time talking, swallowing, and breathing.

Doctors use two types of surgery to treat Chiari type I malformation and syringomyelia. In the first type, called posterior fossa decompression, the surgeon removes a small section of bone at the back of the skull to reduce pressure on the brain. In the second type of surgery, called duraplasty, the surgeon does the same procedure and opens the cover of the brain, called the dura. The surgeon then sews in a patch of tissue to make the dura bigger and relieve pressure on the brain.

One in five patients have complications from duraplasty, such as infection. To avoid complications, some patients opt not to have duraplasty. But if decompression without duraplasty does not ease symptoms, patients may need to have a second surgery.

Doctors don’t know whether either type of surgery is more effective for relieving symptoms. In this study, the research team is comparing decompression with and without duraplasty to see how well each type of surgery relieves symptoms and if either causes less harm. The team is also comparing the two approaches on quality of life after surgery.

Who can this research help?

Study results may help patients with Chiari type I malformation and syringomyelia make decisions with their doctors about surgery options.

What is the research team doing?

The research team is enrolling 148 patients ages 0 to 21 years with Chiari type I malformation and syringomyelia. The team is assigning patients, by chance, to have decompression surgery with or without duraplasty. Patients return to the surgeon’s office three times after surgery for a nervous system exam. At these visits, patients complete two surveys about their symptoms and quality of life. One year after surgery, patients have a brain and spine scan to measure the size of their cyst.

Clinicians, caregivers, and patients help plan and monitor the study and share results.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Children and young adults ≤21 years old with Chiari malformation type I ≥5 mm tonsillar ectopia, syrinx between 3 mm and 6 mm, and Chiari Severity Index classification 1
Interventions/
Comparators
  • Posterior fossa decompression surgery
  • Posterior fossa decompression surgery with duraplasty
Outcomes

Primary: complications of surgery (e.g., cerebrospinal fluid leaks, infections, meningitis)

Secondary: size of syrinx, quality of life

Timeframe 12-month follow-up for primary outcome

Project Details

Principal Investigator
David Limbrick, MD, MS, PhD
Project Status
In progress; Enrollment complete
Project Title
Posterior Fossa Decompression with or without Duraplasty for Chiari Type I Malformation with Syringomyelia
Board Approval Date
September 2015
Project End Date
December 2021
Organization
Washington University School of Medicine
Year Awarded
2015
State
Missouri
Project Type
Research Project
Health Conditions  
Neurological Disorders
Rare Diseases
Intervention Strategies
Other Clinical Interventions
Training and Education Interventions
Populations
Children -- 18 and under
Individuals with Rare Disease
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Project Budget
$2,590,076
Study Registration Information
HSRP20162124
NCT02669836
Page Last Updated: 
October 16, 2020

Research & Results

  • Explore Our Portfolio
  • Research Fundamentals
  • Research Results Highlights
  • Putting Evidence to Work
  • Peer Review
  • Evidence Synthesis
  • About Our Research

About Us

  • Our Programs
  • Governance
  • Financials and Reports
  • Procurement Opportunities
  • Our Staff
  • Our Vision & Mission
  • Contact Us

Research & Results

  • Explore Our Portfolio
  • Research Fundamentals
  • Research Results Highlights
  • Putting Evidence to Work
  • Peer Review
  • Evidence Synthesis
  • About Our Research

Engagement

  • The Value of Engagement
  • Engagement in Health Research Literature Explorer
  • Influencing the Culture of Research
  • Engagement Awards
  • Engagement Resources
  • Engage with Us

Funding Opportunities

  • What & Who We Fund
  • What You Need to Know to Apply
  • Applicant Training
  • Merit Review
  • Awardee Resources
  • Help Center

Meetings & Events

January 21
Cycle 1 2021 Broad PFA Applicant Town Hall
February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021

PCORI

Footer contact address

Patient-Centered Outcomes
Research Institute

1828 L Street, NW, Suite 900
Washington, DC 20036
Phone: (202) 827-7700 | Fax: (202) 355-9558
[email protected]

Subscribe to Newsletter

Twitter Facebook LinkedIn Vimeo

© 2011-2021 Patient-Centered Outcomes Research Institute. All Rights Reserved.

Privacy Policy | Terms of Use | Trademark Usage Guidelines | Credits | Help Center