N/A
N=162
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation · Syringomyelia
Bottom Line
View on ClinicalTrials.gov: NCT02669836 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Posterior fossa decompression (Procedure); Dural Augmentation (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Surgical Complications |
8; 10 | — |
| SECONDARY Aim 2: The Number of Patients With Clinical Improvement |
43; 43 | — |
| SECONDARY Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery. |
1.06; 3.07 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≤21 years old
- Chiari malformation type I ≥5 mm tonsillar ectopia
- Syrinx between 3 mm and 6 mm
- Chiari Severity Index (CSI) classification 1
- 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
- CSI-2 or CSI-3 classification
- Syrinx <3 mm and/or ≥6 mm
- Neuro-imaging demonstrating basilar invagination
- Clival canal angle <120° (signs of severe craniovertebral junction disease)
- Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
- Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
- Patients who do not wish to participate
Data sourced from ClinicalTrials.gov (NCT02669836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.