Clinical trial NCT05754554: Clinical Study of the Treatment of Chiari Malformation Combined With Type II Skull Base Depression
Official title: Clinical Study of Atlanto-occipital Decompression Lateral Joint Release Combined With Occipital-neck Fusion in the Treatment of Chiari Malformation Combined With Type II Skull Base Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atlantoaxial Dislocation
Chiari Malformation
Basilar Invagination
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research background of this study is that Chiari malformation (CM) is a congenital malformation in the foramen magnum region, often associated with syringomyelia, basilar depression, odontoid dislocation and other craniocervical junction deformities. The traditional surgical method for Chiari malformation with skull basilar depression is simple decompression without fixation, so it cannot effectively maintain the stability of the cervical spine and reduce the compression of the brainstem and cervical cord, often resulting in poor curative effect and aggravated symptoms. The cervical spine is the most flexible and most mobile part of the spine, and the instability of the cervical spine will directly affect the quality of life of patients after surgery. Subsequently, with the continuous advancement of technology and the continuous development and improvement of surgical methods, Investigators can relieve spinal cord compression by using atlanto-occipital decompression and dissection followed by C1/2 lateral arthrolysis combined with occipitocervical fusion. So, is this surgical combination the most effective surgery for patients with Chiari malformation and type II skull basilar depression? How should doctors adjust to the best surgical approach to treat patients with Chiari malformation and type II skull basilar depression? These questions have long puzzled neurosurgeons. By conducting this research, investigators hope that participants can participate in it, and work with them to answer this question, and jointly promote the development and progress of doctors' careers, while benefiting more patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Chiari malformation
* Combined with type II skull base depression
* Clinical symptoms related to the disease
* Complete clinical imaging data
* Must be the first surgery

Exclusion Criteria:

* Secondary cerebellar tonsillar hernia
* Severe atlantoaxial dislocation
* Osteochondroplastica
* Rheumatoid arthritis
* Down syndrome
* Refurbished case reoperation

Primary outcomes:
measure: Chang of Chicago Chiari outcome score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Occurrence of complications
timeFrame: The second week after surgery
measure: Chang of Magnetic Resonance Imaging
timeFrame: through study completion, an average of 1 year
measure: Chang of Visual Analog Score for pain
timeFrame: through study completion, an average of 1 year
measure: Chang of Japanese Orthopaedic Association Scores
timeFrame: through study completion, an average of 1 year
measure: Chang of Neck Disability Index
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nan fang hospital, Southern medical university
state: Guangdong
Study officials:
affiliation: 2Nanfang Neurology Research Institution, Nanfang Hospital, Southern Medical University
name: yutao lu
role: STUDY_CHAIR
References: