Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- The Number of Participants With Surgical Complications
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Aim 2: The Number of Patients With Clinical Improvement(10-14 months)
- Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.(10-14 months)