Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation
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
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
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
Wang Shenglin
Clinical Professor
Peking University Third Hospital
