A New Surgery Platform for Calcaneal Surgery: a Clinical Research

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.

Study Overview

• Status: Completed
• Conditions: Calcaneus Fracture
• Intervention / Treatment: Procedure: different types of surgery platforms

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: different types of surgery platforms; 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 in the groups.
Experimental: 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	Procedure: different types of surgery platforms; 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 in the groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sliding frequency of the affected limb during a surgery with two methods	More or fewer times	Intraoperative
The time patients'surgical position can last for in a surgery.	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.	Intraoperative
The frequency of the surgical instruments fall with different methods	More or fewer times	Intraoperative
The whole satisfaction level of the patients and medical staffs	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.	From the beginning of operation till 1 days postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 24, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 20190810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No