Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of Neck Disability Index (NDI)
研究概览
简要总结
Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are diagnosed with degenerative cervical kyphosis with stenosis
- •Patients aged between 30 and 70 years
- •Patients meet the indications for surgery
- •Patients submitted written informed consent
排除标准
- •Tumor, infection, or trauma of the cervical spine
- •Severe cervical kyphosis that greater than 50°
- •Severe ossification of the posterior longitudinal ligament of the cervical spine
- •Patients with ankylosing spondylitis
- •Previous surgery of the cervical spine
结局指标
主要结局
Change of Neck Disability Index (NDI)
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Cross-sectional area of the spinal canal
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
Change of Japanese Orthopaedic Association Score (JOA)
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Total score 0-17. The lower the score the more severe the deficits.
Change of Sagittal Lordosis Angle
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
次要结局
- Change of Range of Motion(baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment)
- Change of Pain Scores on the Visual Analog Scale (VAS)(baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment)
- Complication rate(baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment)
- Reoperation rate(1 month, 3 months, 6 months, 12 months and 24 months post-treatment)
研究者
Xuhua Lu
Director of Traumatic Orthopaedic Department
Shanghai Changzheng Hospital