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Clinical Study of the Treatment of Chiari Malformation Combined With Type II Skull Base Depression

S

Southern Medical University

Status

Enrolling

Conditions

Atlantoaxial Dislocation
Basilar Invagination
Chiari Malformation

Treatments

Procedure: Atlas occipital decompression lateral joint release combined with occipital-neck fusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05754554
NFEC-2022-440

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Central trial contact

yutao lu

Data sourced from clinicaltrials.gov

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