Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- C2-C7 Lordosis
研究概览
简要总结
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
详细描述
Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.
There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1~3 year
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 (Participant)
盲法说明
Using a generator of www.randomization.com, 100 subjects randomized into blocks of 50 and 50. To reproduce this plan, use the seed 3169 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.
and (case-sensitive) treatment labels as entered originally. After randomization of 100 subjects, additional 26 subjects randomized into blocks of 13 and13. To reproduce this plan, use the seed 5134 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical stenosis patients with or without cervical myelopathy.
排除标准
- •Metastatic cancer patients.
- •Any combined fracture.
- •Previous surgery to cervical spine.
- •inflammatory joint disease
- •psychiatric illness
结局指标
主要结局
C2-C7 Lordosis
时间窗: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
the Neck Disability Index (NDI)
时间窗: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
次要结局
- C2-C3 Interlaminar Spontaneous Fusion(at 2 year)
- T1 Slope Minus Cervical Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- EuroQol Five-dimensional Questionnaire (EQ-5D) Scores(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- T1 Slope(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- C2-C3 Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- C4-C7 Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Cervical Sagittal Vertical Axis (cSVA)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Operative Time(Intraoperative)
- Posterior Neck With Numering Rating Scale (NRS-N)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Upper Limb Pain With Numering Rating Scale (NRS-L)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Estimated Intraoperative Blood Loss(Intraoperative)
研究者
Chun Kee Chung
Professor
Seoul National University Hospital