Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- change of cervical alignment
研究概览
简要总结
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.
详细描述
This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with arm pain not responding to conservative treatment
- •lasted longer than 10 weeks
- •single level disc degeneration
- •mobile spine on dynamic lateral cervical X-rays
排除标准
- •severe cardiopulmonary comorbidity
- •suspected underlying malignant disease
- •radicular syndrome
- •spinal-cord compression syndrome
- •contraindication for radiography
研究组 & 干预措施
grade 1
ACD
干预措施: ACD (Procedure)
grade 2
ACDF
干预措施: ACDF (Procedure)
grade 3
ACDA
干预措施: ACDA (Procedure)
结局指标
主要结局
change of cervical alignment
时间窗: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
The Harrison posterior tangent method was used as an estimate for curvature
次要结局
- quality of life(1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years)
研究者
Zhu Zhenqi
department of spinal surgery
Peking University People's Hospital