Chiari Malformation Clinical Trials

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Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study

Status: Completed
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
Beijing
Time Frame
Start Date: 2024-01-31
Completion Date: 2026-02-12
Participants
Target number of participants: 250
Treatments
Experimental: Posterior fossa decompression with duraplasty
In brief, a midline incision was made from the inion to the C2 level. A piece of autologous fascia was harvested from the muscular fascia layer. Paraspinal muscles were dissected to expose the occipital bone, posterior arch of the atlas and axis, spinous process, and lamina. The inferior portion of the occipital bone and approximately 2 cm of the posterior arch of C1 were removed, achieving bony decompression (approximately 2.5-3 × 2.5-3 cm). Once the dura was exposed, the atlanto-occipital membrane was coagulated and dissected off the dura. The dura was then incised in a Y-shaped fashion, with care taken to preserve the underlying arachnoid. Watertight duraplasty was performed using the autologous fascia. The wound was closed in anatomical layers.
Experimental: PFDD with tonsillar resection/reduction
Briefly, a midline incision approximately 3-4 cm posterior to the foramen magnum is made. The incision is deepened layer by layer along the midline to reach the occipital bone, exposing the posterior margin of the foramen magnum and part of the occipital squama. The posterior edge of the foramen magnum is opened, and part of the occipital squama is removed up to the junction of the cerebellar vermis and cerebellar tonsils. The occipitoatlantal fascia is exposed and dissected. The dura mater and arachnoid mater are incised longitudinally and suspended bilaterally to provide a clear surgical field. The primary objectives of resection were: ensuring no significant obstruction of CSF circulation at the foramen magnum and the foramen of Magendie under natural conditions. Preventing occlusion of the foramen of Magendie caused by herniated cerebellar tonsils or any membranous structures under natural conditions. The dura is closed in situ.
Sponsors
Collaborators: The First Hospital of Hebei Medical University, Beijing Jiangong Hospital
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov