Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Status: | Active, not recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 3/29/2019 |
Start Date: | April 2016 |
End Date: | May 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: David Limbrick, M.D., PhD.
Phone: 314-454-4454
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