Chiari Malformation Type I, Tonsillectomy
Conditions
Keywords
posterior fossa decompression with duraplasty, tonsillectomy, foramen magnum and foramen of Magendie dredging, chiari malformation, syringomyelia
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 improved quality of life in those who have Chiari malformation type I and syringomyelia.
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 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 surgery.
Interventions
PROCEDUREPosterior 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.
PROCEDUREPFDD 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
Xuanwu Hospital, Beijing
The First Hospital of Hebei Medical University
Beijing Jiangong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement or resolution of the syrinx, | 3-6, 12 and 24 months | defined as \> 50% improvement in length, maximal cross-sectional diameter, or both. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complication rates | 12 months | Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications |
| Chicago Chiari Outcome Scale (CCOS) scale | 12 months | for evaluating the spinal cord function after chiari decompression surgery, Each item is scored on a scale from 1 to 4, with 4 representing the best possible functional status. |
| visual analog scale (VAS) | 12 months | degree of the pain, 1-10, higher scores mean a worse outcome |
| Japanese Orthopaedic Association (JOA) scale | 12 months | Motor function， sensory， bladder function；for evaluating the spinal cord function；0-17， higher scores mean a better outcome |
| blood loss | 12 months | blood loss |
| hospital stay | 12 months | hospital stay |
| cost for the hospitalisation. | 12 months | cost for the hospitalisation. |
Countries
China
Contacts
STUDY_CHAIRfengzeng jian
Xuanwu Hospital, Beijing
Outcome results
None listed