A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 31
- 主要终点
- Cervical fusion status
研究概览
简要总结
The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative cervical disease
- •radiculopathy or myelopathy refractory to conservative treatment
- •be scheduled to undergo one segment anterior cervical discectomy and fusion
- •age is more than 19 years old
- •all requirements of preoperative image studies are satisfied
排除标准
- •previous neck surgery or radiation treatments at neck area
- •fusion at adjacent segments
- •two segment fusion is expected
- •C2-3 or C7-T1
- •high risk for additional cervical surgery within one year
- •ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
- •inadequate radiological images
- •patient is not expected to be observed at long term follow-up (foreigner, international student)
研究组 & 干预措施
Cage and Plate
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
干预措施: anterior cervical discectomy and fusion (Procedure)
Cage and Plate
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
干预措施: Cage and Plate (Device)
Cage alone
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
干预措施: anterior cervical discectomy and fusion (Procedure)
Cage alone
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
干预措施: Cage alone (Device)
结局指标
主要结局
Cervical fusion status
时间窗: five year after surgery
Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.
次要结局
- change of neck motion after surgery(one year after surgery)
- correlation between osteoporosis and fusion(one year after surgery)
- relation between brace wearing and fusion(one year after surgery)
- surgical outcomes for combined uncinectomy(one year after surgery)
- neuropathy after anterior cervical discectomy and fusion surgery(one year after surgery)
- The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)(one year after surgery)
- risk factors for adjacent segment degeneration(five year after surgery)
- predisposing factor of non-union(one year after surgery)
- risk factors of dysphagia(one year after surgery)
- risk factors of dysphonia(one year after surgery)
- factors for quality of life(one years after operation)
- analysis of complication rates after anterior cervical discectomy and fusion surgery(one year after surgery)
- relation between the method of bone graft and fusion(one year after surgery)
- The correlation between existence of co-morbidity and surgical outcome(one year after surgery)
研究者
Jin S. Yeom
Associate Professor
Seoul National University Hospital