CompletedNot Applicable

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

United States162 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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

What they're measuring

The Number of Participants With Surgical Complications

Timeframe: less then or equal to 6 months from decompression

Trial details

NCT IDNCT02669836

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-31

Results submitted2021-11-15

View on ClinicalTrials.gov More Arnold-Chiari Malformation, Type 1 trials