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临床试验/NCT05754554
NCT05754554已完成不适用

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

Southern Medical University, China1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Chang of Chicago Chiari outcome score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Atlas occipital decompression lateral joint release combined with occipital-neck fusion (Procedure)

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).

干预措施: Simple FMD with Outer Dural Delamination (Procedure)

结局指标

主要结局

Chang of Chicago Chiari outcome score

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Southern Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuntao Lu

Clinical Professor

Southern Medical University, China

研究点 (1)

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