跳至主要内容
临床试验/NCT06233539
NCT06233539招募中不适用

A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
The incidence of special attention adverse events in patients within 12 months after surgery

研究概览

简要总结

The most effective treatment for atlantoaxial dislocation is surgical treatment, with the principle of achieving reduction, reconstruction, and fusion of the atlantoaxial joint. The surgical strategies mainly include simple anterior approach, simple posterior approach, and combined anterior posterior approach. The investigators have summarized 904 cases of atlantoaxial instability or dislocation from 1998 to 2010 and preliminarily published the diagnosis and treatment strategy tree of the Third Hospital of Beijing Medical University. This strategy is divided into four types based on the severity of atlantoaxial dislocation: unstable, reversible, difficult to recover, and skeletal, and enters different surgical treatment processes. With the increase in the number of cases, accumulation of experience, and technological improvements in the past decade, spinal surgery colleagues have updated their classification diagnosis, diagnosis and treatment processes, and surgical techniques for atlantoaxial instability or dislocation.

However, the selection of treatment strategies for atlantoaxial dislocation is mostly based on the surgeon's own experience, and there is a lack of standardized, large-scale, and high-level evidence-based medical research on the safety and effectiveness of current empirical strategies. Based on this, this study intends to adopt a multicenter, retrospective, and prospective study to construct a high-quality clinical cohort of atlantoaxial dislocation, update the classification and diagnosis and treatment strategies of atlantoaxial dislocation. And conduct long-term follow-up on patients to evaluate their safety and effectiveness, guide the surgical treatment of atlantoaxial dislocation, and thus form a recognized diagnostic and treatment standard for atlantoaxial dislocation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with atlantoaxial dislocation and treated with surgery

排除标准

  • Disagree to participate in this study.

结局指标

主要结局

The incidence of special attention adverse events in patients within 12 months after surgery

时间窗: 12 month follow up

The proportion of adverse events occurring in patients during the study period to the total number of study patients. Recording and reporting of adverse events, including: • deterioration of neurological function * Incision infection * Vascular injury Airway obstruction Poor reset • Unplanned readmission and unplanned reoperation • Internal fixation failure Fusion failure Surgical related lower cervical spine deformities

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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