Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Number of Participants With Bone Fusion
研究概览
简要总结
Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. In the present study, the investigators are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.
详细描述
Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony fusion rate may be increased because of low thermal injury to the bone. In the present study, we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.
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
- Double (Participant, Outcomes Assessor)
盲法说明
ultrasonic bone osteotome
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;
- •aged more than 20 years
- •with American Society of Anesthesiology physical status class 1 or 2
排除标准
- •concomitant neurological disease such as cerebral palsy or amyotrophic lateral sclerosis; 2) concurrent cancer or infection; 3) previous cervical spinal surgery; 4) a trauma-associated lesion; 5) inability to be followed up (i.e., foreign patients); 6) refusal to participate in the study
研究组 & 干预措施
Ultrasonic osteotome
making gutter on the hinge side of lamina with ultrasonic osteotome
干预措施: ultrasonic osteotome (Device)
Drill
making gutter on the hinge side of lamina with conventional drill
干预措施: drill (Device)
结局指标
主要结局
Number of Participants With Bone Fusion
时间窗: 6 months
Bone fusion based on computed tomography scan taken at postoperative 6 months
次要结局
- Bleeding Amount(during operation)
- Fracture of Laminar(during operation)
- Neck Pain/Arm Pain(postop 1 year)
- Functional Outcome(postop 1 year)
研究者
Chun Kee Chung
Professor
Seoul National University Hospital