Trials / Completed
CompletedNCT02669836
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Arnold-Chiari Malformation, Type 1
- Chiari Malformation Type I
- Type I Arnold-Chiari Malformation
- Syringomyelia
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Posterior fossa decompression | 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. |
| PROCEDURE | Dural Augmentation | 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. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-07-31
- Completion
- 2020-07-31
- First posted
- 2016-02-01
- Last updated
- 2024-10-31
- Results posted
- 2024-10-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02669836. Inclusion in this directory is not an endorsement.