Status:
RECRUITING
PFDD Versus PFDRT in Chiari Decompression Surgery
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Chiari Malformation Type I
Tonsillectomy
Eligibility:
All Genders
14-80 years
Phase:
NA
Brief 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 imp...
Detailed Description
Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. The participant wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06079125
Start Date
October 1 2023
End Date
December 1 2027
Last Update
October 12 2023
Active Locations (1)
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1
Fengzeng Jian
Beijing, Beijing Municipality, China, 100053