PFDD Versus PFDRT in Chiari Decompression Surgery (NCT06079125) | Clinical Trial Compass
CompletedNot Applicable
PFDD Versus PFDRT in Chiari Decompression Surgery
China250 participantsStarted 2024-01-31
Plain-language summary
The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation 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 range14 Years – 80 Years
SexALL
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Inclusion Criteria:
* Age ≥14 years old
* Chiari malformation type I ≥5 mm tonsillar ectopia
* a syrinx with a width \> 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments.
* 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:
* included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess;
* other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., Klippel-Feil, atlas assimilation, etc.);
* degenerative or demyelinating disease;
* CM-I without syringomyelia;
* syringomyelia with cerebellar tonsils in a normal position;
* fibromyalgia;
* chronic fatigue syndrome;
* prior posterior fossa surgery.
* Unable to share pre-decompression MRI of the brain and spine Patients who do not wish to participate