A New Surgery Platform for Calcaneal Surgery: a Clinical Research

Not Applicable

Completed

• Conditions: Calcaneus Fracture
• Interventions: Procedure: different types of surgery platforms

• Registration Number: NCT04070274
• Lead Sponsor: Yangzhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-24
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Ages ranged from 18 to 82.
• ASA Ⅰ or Ⅱ level.

Exclusion Criteria

• Limited body activity and extremely severe cardiovascular diseases.
• Unwilling to cooperate.
• Mental illness and coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New surgery platform for calcaneal surgery	different types of surgery platforms	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.
Traditional lateral platform	different types of surgery platforms	The traditional lateral position makes the surgery platform "bread-shaped arch" surface by using medical mats and putting lower limbs superimpose on each other

Primary Outcome Measures

Name	Time	Method
The time patients'surgical position can last for in a surgery.	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	Intraoperative	More or fewer times
The frequency of the surgical instruments fall with different methods	Intraoperative	More or fewer times
The whole satisfaction level of the patients and medical staffs	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.

Secondary Outcome Measures

Name	Time	Method
Extra possible adverse effects due to the new surgical platform	From the beginning of operation till 24 hours postoperative	Check adverse effects on the basis of influences on respiratory or circulatory systems and damages on patients' nerves or skin.