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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
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.
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.
Fengzeng Jian
Beijing, Beijing Municipality, China
improvement or resolution of the syrinx,
defined as \> 50% improvement in length, maximal cross-sectional diameter, or both.
Time frame: 3-6, 12 and 24 months
complication rates
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Time frame: 12 months
Chicago Chiari Outcome Scale (CCOS) scale
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.
Time frame: 12 months
visual analog scale (VAS)
degree of the pain, 1-10, higher scores mean a worse outcome
Time frame: 12 months
Japanese Orthopaedic Association (JOA) scale
Motor function, sensory, bladder function;for evaluating the spinal cord function;0-17, higher scores mean a better outcome
Time frame: 12 months
blood loss
blood loss
Time frame: 12 months
hospital stay
hospital stay
Time frame: 12 months
cost for the hospitalisation.
cost for the hospitalisation.
Time frame: 12 months
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