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

The Washington University

Status: Completed

Conditions: Arnold-Chiari Malformation, Type 1; Syringomyelia; Type I Arnold-Chiari Malformation; Chiari Malformation Type I

Treatments: Procedure: Dural Augmentation; Procedure: Posterior fossa decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT02669836

PCORI275- 201604044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Posterior fossa decompression surgery

Experimental group

Description:

The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected

Treatment:

Procedure: Posterior fossa decompression

Dural augmentation surgery

Experimental group

Description:

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.

Treatment:

Procedure: Dural Augmentation