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

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The Washington University

Status

Completed

Conditions

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

Treatments

Procedure: Posterior fossa decompression
Procedure: Dural Augmentation

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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