Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Estimated Blood Loss/Level
研究概览
简要总结
The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.
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)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-18 years of age
- •Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- •Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
排除标准
- •Plan for a posterior column osteotomy of Schwab Grade II or higher
- •Prior spinal surgery
- •Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
- •Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
- •Subjects with bleeding diatheses
- •Non-idiopathic etiology for scoliosis
研究组 & 干预措施
Ultrasonic Bone Scalpel Group
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
干预措施: Posterior Spinal Fusion (Procedure)
Standard of Care Group
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
干预措施: Posterior Spinal Fusion (Procedure)
Ultrasonic Bone Scalpel Group
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
干预措施: Ultrasonic Bone Scalpel (Device)
结局指标
主要结局
Estimated Blood Loss/Level
时间窗: Intraoperative
Estimated blood loss is being obtained from the report generated by the cell saver.
次要结局
- Procedure Time (Minutes)(Intraoperative (for duration of the procedure))
- Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group(Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery))