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

May 9, 2023 updated by: Yuntao Lu, Southern Medical University, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nan fang hospital, Southern medical university
        • Contact:
          • Chongyuan Xu, Ph.D
          • Phone Number: +8620-62787238
        • Principal Investigator:
          • Yuntao Lu, M.D., Ph.D
        • Sub-Investigator:
          • Lin Pen, M.D.
        • Sub-Investigator:
          • Hai Wang, M.D., Ph.D
        • Sub-Investigator:
          • Jin Shi, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chang of Chicago Chiari outcome score
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of complications
Time Frame: The second week after surgery
1)Minor complications such as pain, neck stiffness, and poor wound healing. 2)Serious complications such as vertebral artery injury, dyspnea, cerebrospinal fluid leakage, and severe intracranial infection.
The second week after surgery
Chang of Magnetic Resonance Imaging
Time Frame: through study completion, an average of 1 year
Measurements of radiographic improvement, such as cerebellar tonsillar hernia length.
through study completion, an average of 1 year
Chang of Visual Analog Score for pain
Time Frame: through study completion, an average of 1 year
Visual Analog Score stands for visual analogue scoring method and is one of the commonly used pain scoring criteria. The main thing is to draw a 10cm horizontal line on the paper, the beginning end is 0, the other end is 10, the middle part represents different degrees of pain, let the patient choose the degree of pain by himself. A score below 3 represents mild pain; 4-6 are divided into pain that interferes with sleep, but is tolerable; A score of 7-10 indicates unbearable pain.
through study completion, an average of 1 year
Chang of Japanese Orthopaedic Association Scores
Time Frame: through study completion, an average of 1 year
The patient's lumbar spine function and improvement were mainly evaluated from four aspects: subjective symptoms, daily activity ability, clinical signs, and bladder function. The scoring range is 0~29 points, and the higher the total score, the milder the patient's condition.
through study completion, an average of 1 year
Chang of Neck Disability Index
Time Frame: through study completion, an average of 1 year
Neck Disability Index consists of 10 items, including: neck pain and related symptoms (pain intensity, headache, concentration and sleep) and activities of daily living (personal care, lifting heavy objects, reading, work, driving and playing). Each item has a minimum score of 0 and a maximum score of 5, with higher scores indicating greater levels of dysfunction.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Medical University, China

Investigators

  • Study Chair: yutao lu, 2Nanfang Neurology Research Institution, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

December 12, 2023

Study Completion (Anticipated)

December 12, 2024

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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