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

Primary Purpose

Atlantoaxial Dislocation, Chiari Malformation, Basilar Invagination

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atlas occipital decompression lateral joint release combined with occipital-neck fusion
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atlantoaxial Dislocation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Nan fang hospital, Southern medical universityRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of complications
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.
Chang of Magnetic Resonance Imaging
Measurements of radiographic improvement, such as cerebellar tonsillar hernia length.
Chang of Visual Analog Score for pain
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.
Chang of Japanese Orthopaedic Association Scores
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.
Chang of Neck Disability Index
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.

Full Information

First Posted
January 28, 2023
Last Updated
May 9, 2023
Sponsor
Southern Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05754554
Brief Title
Clinical Study of the Treatment of Chiari Malformation Combined With Type II Skull Base Depression
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atlantoaxial Dislocation, Chiari Malformation, Basilar Invagination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Atlas occipital decompression lateral joint release combined with occipital-neck fusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chang of Chicago Chiari outcome score
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Occurrence of complications
Description
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.
Time Frame
The second week after surgery
Title
Chang of Magnetic Resonance Imaging
Description
Measurements of radiographic improvement, such as cerebellar tonsillar hernia length.
Time Frame
through study completion, an average of 1 year
Title
Chang of Visual Analog Score for pain
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Chang of Japanese Orthopaedic Association Scores
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Chang of Neck Disability Index
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yutao lu
Phone
13632101002
Email
lllu2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yutao lu
Organizational Affiliation
2Nanfang Neurology Research Institution, Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nan fang hospital, Southern medical university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chongyuan Xu, Ph.D
Phone
+8620-62787238
First Name & Middle Initial & Last Name & Degree
Yuntao Lu, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Lin Pen, M.D.
First Name & Middle Initial & Last Name & Degree
Hai Wang, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Jin Shi, Master

12. IPD Sharing Statement

Plan to Share IPD
No

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

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