A New Surgery Platform for Calcaneal Surgery: a Clinical Research

NCT04070274 | Completed

• 1 other identifier: 20190810
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Calcaneus Fracture

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Extra possible adverse effects due to the new surgical platform

  From the beginning of operation till 24 hours postoperative

Study Arms (2)

New surgery platform for calcaneal surgery

EXPERIMENTAL

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

Traditional lateral platform

EXPERIMENTAL

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

Interventions

different types of surgery platforms PROCEDURE

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.

New surgery platform for calcaneal surgery; Traditional lateral platform

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yangzhou University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08