A New Surgery Platform for Calcaneal Surgery: a Clinical Research

Calcaneus Fracture Clinical Trial

Official title:

A New Surgery Platform for Calcaneal Surgery: a Clinical Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070274
• Other study ID #: 20190810
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Ages ranged from 18 to 82.

• ASA ? or ? level.

Exclusion Criteria:

• Limited body activity and extremely severe cardiovascular diseases.

• Unwilling to cooperate.

• Mental illness and coagulopathy

Related Conditions & MeSH terms

• Calcaneus Fracture

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sliding frequency of the affected limb during a surgery with two methods	More or fewer times	Intraoperative
Primary	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
Primary	The frequency of the surgical instruments fall with different methods	More or fewer times	Intraoperative
Primary	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	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