跳至主要内容
临床试验/NCT05876611
NCT05876611尚未招募不适用

Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage: a Cohort Study

Peking University Third Hospital0 个研究点目标入组 400 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
fusion rate

研究概览

简要总结

Conventional open surgery often requires extensive dissection of the muscle insertion points of the suboccipital muscle group during the insertion position and direction of the atlas axis screw, resulting in sustained postoperative occipital neck pain and movement dysfunction. In order to overcome the shortcomings of the prior art mentioned above, the present invention provides a self stabilizing fusion cage with a wing plate. During surgery, a thinner and smaller screw through the wing plate is used to achieve a secure connection between the atlas axis and the fusion cage. Due to the smaller screw size, the screw placement has higher safety. The purpose of this study is to compare the advantages of using this new fusion cage compared to traditional surgical instruments.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Atlantoaxial dislocation
  • Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible
  • Sign an informed consent form;

排除标准

  • Atlantoaxial dislocation without surgical treatment
  • Patients who refuse to participate in this project

结局指标

主要结局

fusion rate

时间窗: 12 month follow up

Postoperative atlantoaxial fusion conditions

complications

时间窗: 12 month follow up

Short or long-term postoperative complications

neural functions

时间窗: 12 month follow up

Postoperative neurological function recovery conditions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验