A New Surgery Platform for Calcaneal Surgery: a Clinical Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- The time patients'surgical position can last for in a surgery.
研究概览
简要总结
Purpose: Study on the method of lateral nursing and surgical operating tables optimization in the calcaneal surgery.
Method:Design combined surgical operating tables grouped according to the time of clinical application.58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied to compare the sliding of the affected limb during a surgery, the stability of the position, the difference of the surgical instruments fall and the satisfaction of the medical staff.Moreover,30 healthy volunteers are selected to experience the comfort level of the two placement methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ranged from 18 to
- •ASA Ⅰ or Ⅱ level.
排除标准
- •Limited body activity and extremely severe cardiovascular diseases.
- •Unwilling to cooperate.
- •Mental illness and coagulopathy
研究组 & 干预措施
New surgery platform for calcaneal surgery
The lateral position surgical platform for calcaneus surgery is designed with a bottom board, mats in front and at back of calf and thigh, and two sizes of cover plates, using "tunnel" principle according to physiological curve of lower limbs.
干预措施: different types of surgery platforms (Procedure)
Traditional lateral platform
The traditional lateral position makes the surgery platform "bread-shaped arch" surface by using medical mats and putting lower limbs superimpose on each other
干预措施: different types of surgery platforms (Procedure)
结局指标
主要结局
The time patients'surgical position can last for in a surgery.
时间窗: Intraoperative
Necessary position stability is significant.For intraoperative fluoroscopy,surgeons need to keep the injured feet a fixing steady position with the help of different platforms.So,time the steady position can last for is recorded by the investigator separately.
The sliding frequency of the affected limb during a surgery with two methods
时间窗: Intraoperative
More or fewer times
The frequency of the surgical instruments fall with different methods
时间窗: Intraoperative
More or fewer times
The whole satisfaction level of the patients and medical staffs
时间窗: From the beginning of operation till 1 days postoperative
Patients and medical staffs are asked for feelings about the utilization of the new surgical platform.Mark 0 is extreme poor.Mark 10 is very perfect,and the numbers between them are comments of varying degrees.
次要结局
- Extra possible adverse effects due to the new surgical platform(From the beginning of operation till 24 hours postoperative)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University