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Completed

NCT Number: NCT04070274

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.

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Key information

Conditions

Calcaneus Fracture

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The sliding frequency of the affected limb during a surgery with two methods

    Time frame: Intraoperative

    More or fewer times

  2. The time patients'surgical position can last for in a surgery.

    Time frame: 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.

  3. The frequency of the surgical instruments fall with different methods

    Time frame: Intraoperative

    More or fewer times

  4. The whole satisfaction level of the patients and medical staffs

    Time frame: 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 outcomes

  1. Extra possible adverse effects due to the new surgical platform

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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