Clinical trial NCT02669836: Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Official title: Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arnold-Chiari Malformation, Type 1
Chiari Malformation Type I
Type I Arnold-Chiari Malformation
Syringomyelia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Johns Hopkins All Children's Hospital
name: Arkansas Children's Hospital Research Institute
name: Boston Children's Hospital
name: Children's Healthcare of Atlanta
name: Dartmouth-Hitchcock Medical Center
name: Children's Hospital Colorado
name: Birmingham Children's Hospital
name: Morgan Stanley Children's Hospital
name: Phoenix Children's Hospital
name: Children's Hospital and Health System Foundation, Wisconsin
name: Children's National Research Institute
name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: Columbia University
name: Gillette Children's Specialty Healthcare
name: Levine Children's Hospital
name: Children's Hospital Los Angeles
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Mayo Clinic
name: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
name: Medical University of South Carolina Shawn Jenkins Children's Hospital
name: Oregon Health and Science University
name: Penn State University
name: University of Pittsburgh
name: Primary Children's Hospital
name: Seattle Children's Hospital
name: Stanford University
name: Baylor College of Medicine
name: The Children's Hospital at OU Medical Center
name: Nationwide Children's Hospital
name: University of California
name: University of Iowa
name: University of Michigan
name: The University of Texas Health Science Center, Houston
name: University of Minnesota
name: University of Vermont
name: UVA Children's Hospital
name: University of Wisconsin, Madison
name: Vanderbilt University
name: Wake Forest University
name: Yale University
First posted: 2016-02-01
Enrollment: 162
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants With Surgical Complications
timeFrame: less then or equal to 6 months from decompression
Secondary outcomes:
measure: Aim 2: The Number of Patients With Clinical Improvement
timeFrame: 10-14 months
measure: Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.
timeFrame: 10-14 months
Other outcomes:
measure: Aim 3 : Mean Change in Quality of Life Measurement After Surgery Relative to Baseline.
timeFrame: 10-14 Months from Decompression
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University-St. Louis Children's Hospital
name: David D Limbrick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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