Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Fengzeng Jian
RECRUITING
Beijing
Contact Information
Primary
fengzeng jian, M.D.
jianfengzeng@xwh.ccmu.edu.cn
+861083198899
Time Frame
Start Date: 2023-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 352
Treatments
Experimental: Posterior fossa decompression with duraplasty
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed.
Experimental: PFDD with tonsillar resection/reduction
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened and herniated tonsil will be manipulated. Microsurgical dissection is performed and the dura is sewn closed.
Related Therapeutic Areas
Sponsors
Leads: Xuanwu Hospital, Beijing