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

NCT ID: NCT05754554

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-12

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.

Conditions

Atlantoaxial Dislocation; Chiari Malformation; Basilar Invagination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yuntao Lu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yutao lu

Role: STUDY_CHAIR

2Nanfang Neurology Research Institution, Nanfang Hospital, Southern Medical University

Locations

Nan fang hospital, Southern medical university

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

yutao lu

Role: CONTACT

lllu2000@163.com

13632101002

Facility Contacts

Chongyuan Xu, Ph.D

Role: primary

+8620-62787238

Other Identifiers

NFEC-2022-440

Identifier Type: -

Identifier Source: org_study_id