PFDD Versus PFDRT in Chiari Decompression Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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 will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

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

Conditions
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Chiari Malformation Type I, Tonsillectomy

Intervention / Treatment
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* Procedure: Posterior fossa decompression with duraplasty
* Procedure: PFDD with tonsillar resection/reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior fossa decompression with duraplasty<br>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. | Procedure: Posterior fossa decompression with duraplasty<br>* The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft.<br>|
| Experimental: PFDD with tonsillar resection/reduction<br>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. | Procedure: PFDD with tonsillar resection/reduction<br>* The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. Then herniated tonsil will be manipulated and adhesion was released. After microsurgical manipulated, the dura is sewn closed with a dural graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement or resolution of the syrinx, | defined as > 50% improvement in length, maximal cross-sectional diameter, or both. | 3-6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rates | Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications | 12 months | 
| Chicago Chiari Outcome Scale (CCOS) scale |  | 12 months | 
| visual analog scale (VAS) | degree of the pain | 12 months | 
| Japanese Orthopaedic Association (JOA) scale | Japanese Orthopaedic Association Scores | 12 months | 
| blood loss | blood loss | 12 months | 
| hospital stay | hospital stay | 12 months | 
| cost for the hospitalisation. | cost for the hospitalisation. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posterior fossa decompression with duraplasty, tonsillectomy, FMDD