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

Washington University School of Medicine162 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Arnold-Chiari Malformation, Type 1 Chiari Malformation Type I Type I Arnold-Chiari Malformation Syringomyelia

Interventions

Posterior fossa decompressionPROCEDURE

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.

Dural AugmentationPROCEDURE

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.

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Louis Children's Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

The Number of Participants With Surgical Complications

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

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

Secondary Outcomes

Aim 2: The Number of Patients With Clinical Improvement

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.

Time frame: 10-14 months

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

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

Time frame: 10-14 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.