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

Not Applicable

Completed

• Conditions: Type I Arnold-Chiari Malformation; Syringomyelia; Chiari Malformation Type I; Arnold-Chiari Malformation, Type 1
• Interventions: Procedure: Dural Augmentation; Procedure: Posterior fossa decompression

• Registration Number: NCT02669836
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2016-04
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Results First Submitted: 2021-11-15
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Results First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dural augmentation surgery	Dural Augmentation	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.
Posterior fossa decompression surgery	Posterior fossa decompression	The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Surgical Complications	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 Outcome Measures

Name	Time	Method
Aim 2: The Number of Patients With Clinical Improvement	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.
Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.	10-14 months	Syrinx regression comparison between posterior fossa decompression surgery and dural augmentation surgery cohorts based on ITT.

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States