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临床试验/NCT06003491
NCT06003491尚未招募不适用

A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

Xuanwu Hospital, Beijing0 个研究点目标入组 164 人开始时间: 2023年9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
164
主要终点
Fusion Rates

研究概览

简要总结

The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up

排除标准

  • The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers

结局指标

主要结局

Fusion Rates

时间窗: 12 months

Atlantoaixal fusion rates

次要结局

  • Visual Analogue Scale(12 months)
  • Neck Disability Index(12 months)
  • Japanese Orthopaedic Association Scores(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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