Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Estimated Blood Loss
研究概览
简要总结
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue
Elevator & Retractor [SISTER] device to assess:
- Effects on operative time and efficiency of exposure in open lumbar spine cases.
- Effect on total blood loss during the exposure part of the operation.
- Rate of clogging of suction device.
详细描述
The device, Suction-Integrated Surgical Tissue Elevator & Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Patients undergoing lumbar one to sacral one open instrumentation
- •Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine
排除标准
- •Less than 22 years old
- •Procedure does not involve instrumentation
- •Prior lumbar spine surgery involving more than one level
- •BMI less than 20 or greater than 35
- •Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
- •Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
- •Operative cases where a single surgeon performs both sides of exposure
- •Pregnant women
- •Prisoners
- •Adults unable to consent
研究组 & 干预措施
Use of Cobb device
Use of SISTER device during surgery
干预措施: SISTER device (Device)
Control
Standard exposure technique and instruments will be used during surgery
结局指标
主要结局
Estimated Blood Loss
时间窗: 1.5 hours
Amount of blood loss from incision time to screw placement
次要结局
- Time of Exposure(1.5 hours)
- Rate of Clogging(1.5 hours)
研究者
Ian Cote
Assistant Professor
University of Miami