跳至主要内容
临床试验/NCT06678711
NCT06678711尚未招募不适用

Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Perioperative Blood Loss

研究概览

简要总结

The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of postoperative occipital cervical pain, and significant blood loss due to intraoperative bleeding and postoperative drainage. Since 2013, various studies have reported minimally invasive posterior atlantoaxial lateral mass joint fusion techniques through muscle spaces, but previous studies were all case reports, without sufficient reliability and controlled studies. The Department of Orthopedics at Peking University Third Hospital has been using the minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Mis-PALF) technique for the treatment of atlantoaxial dislocation since 2015, with preliminary good clinical results. In order to further compare the advantages and disadvantages of the two surgical methods from a larger sample, a randomized controlled study is planned. The patients will be randomly divided into two groups, with the experimental group receiving the Mis-PALF surgery and the control group receiving open atlantoaxial fusion and fixation. There will be a 1-2 year follow-up to compare the safety and effectiveness of the two surgical methods for the treatment of atlantoaxial dislocation.

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
Single (Outcomes Assessor)

入排标准

年龄范围
0 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range from 0 to 80 years old, regardless of gender
  • •Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
  • •Index of assessment integrity
  • •Agree to participate in the study and sign the informed consent

排除标准

  • •Atlantoaxial dislocation without surgical treatment
  • •Atlantoaxial dislocation treated by other operation, such as TARP

研究组 & 干预措施

Minimal invasive surgery arm

Experimental

Patients in minimal invasive surgery arm will receive minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion.

干预措施: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Procedure)

Open atlantoaxial fixation and fusion arm

Active Comparator

Patients in open atlantoaxial fixation and fusion arm will receive atlantoaxial fixation and fusion using the Goel-Harms technique.

干预措施: Open atlantoaxial fixation and fusion (Procedure)

结局指标

主要结局

Perioperative Blood Loss

时间窗: 2 weeks

Blood loss due to intraoperative bleeding and postoperative drainage.

Postoperative Stay

时间窗: 2 weeks

The time from the completion of surgery to the patient leaving hospital.

Level of Occipitocervical Pain

时间窗: 12 months

The level of patients' occipitocervical pain is described by Numerical Rating Scale, from zero to ten, and ten means the most pain.

Main location of occipitocervical pain

时间窗: 12 months

The location of patients' occipitocervical pain is indicated by patients on a diagram illustrating the anatomical regions of the head and neck.

Painkillers Used for Occipitocervical Pain

时间窗: 12 months

Patients are asked about whether they used any painkillers for occipitocervical pain and which painkillers they used.

次要结局

  • Incidence of Adverse Events(12 months)
  • Atlantoaxial Reduction Rate(12 months)
  • Bone Graft Fusion Rate(12 months)
  • Improvement Rate of Quality of Life(12 months)
  • Improvement of Neurological Function(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Shenglin

Clinical Professor

Peking University Third Hospital

研究点 (1)

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