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

August 19, 2024 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
less then or equal to 6 months from decompression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10-14 months
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.
10-14 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10-14 Months from Decompression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimated)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCORI275- 201604044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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