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

NCT05754554 | Completed DMC

• 1 other identifier: NFEC-2022-440
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Chang of Chicago Chiari outcome score

  The Chicago Chiari Malformation Prognosis Scale (CCOS) is a comprehensive quantitative scoring criterion for surgical prognosis in patients with Chiari malformations, first proposed by the Department of Neurosurgery of the University of Chicago School of Medicine. CCOS covered four scoring criteria, including improvement in pain symptoms, improvement in non-pain symptoms, ability to live, and surgery-related complications, with a single score of 1-4 for a total score of 4 to 16, and at the last follow-up, the higher the patient's score indicated the better the patient's postoperative prognosis.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Occurrence of complications

  The second week after surgery

• Chang of Magnetic Resonance Imaging

  through study completion, an average of 1 year

• Chang of Visual Analog Score for pain

  through study completion, an average of 1 year

• Chang of Japanese Orthopaedic Association Scores

  through study completion, an average of 1 year

• Chang of Neck Disability Index

  through study completion, an average of 1 year

Study Arms (2)

Experimental: FMD + C1/2 Facet Release + OCF

EXPERIMENTAL

All patients underwent preoperative dynamic CT scans in flexion, neutral, and extension positions, and all were treated surgically with atlanto-occipital decompression, CI/2 lateral articular release, combined with occipital-cervical fusion.

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

Active Comparator: Simple FMD + Outer Dural Delamination

ACTIVE COMPARATOR

Patients in this arm will receive the traditional standard procedure, which consists of simple bony foramen magnum decompression combined with outer dural delamination (without opening the inner layer of the dura mater to reduce complications).

Procedure: Simple FMD with Outer Dural Delamination

Interventions

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

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.

Experimental: FMD + C1/2 Facet Release + OCF

Simple FMD with Outer Dural Delamination PROCEDURE

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.

Active Comparator: Simple FMD + Outer Dural Delamination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Nan fang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• yutao lu

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: March 6, 2023
• Study Start: March 1, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 16, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)