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

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.

Conditions

• Atlantoaxial Dislocation
• Chiari Malformation
• Basilar Invagination

Interventions

PROCEDURE

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

A. Chiari malformation combined with type II Basilar invagination showed that the slope spinal canal angle decreased, and the position of the dentition moved up. The yellow fusion device in the picture is C1/2 lateral inter-articular Cage (the patent granted by the applicant for this project); B. After atlanto-occipital decompression, C1/2 lateral inter-articular release is performed, and a fusion device is implanted to move down the position of the tip of the tooth process to reduce the compression of the cervical medulla oblongata; C. Implantation of the posterior neck nail rod system; D. Improve the angle of the sloped spinal canal by posterior compression rod technique (Cantilever) to further reduce the compression on the superior cervical medulla oblongata.

PROCEDURE

Simple FMD with Outer Dural Delamination

This arm utilizes the traditional standard strategy, distinct from the comprehensive fusion in the experimental arm. The specific distinguishing details are: Performing strictly anatomical decompression ONLY. This involves bony foramen magnum decompression combined with outer dural delamination (without opening the inner layer of the dura mater). This arm specifically EXCLUDES C1/2 facet joint release, cage implantation, and any form of occipitocervical internal fixation or biomechanical reconstruction.

Sponsors & Collaborators

• Southern Medical University, China

  lead OTHER

Principal Investigators

• yutao lu · 2Nanfang Neurology Research Institution, Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2024-12-12

Completion

2024-12-16

Countries

• China

Study Locations