A New Surgery Platform for Calcaneal Surgery: a Clinical Research

NCT ID: NCT04070274

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-08-31

Brief Summary

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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

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Conditions

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Calcaneus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

different types of surgery platforms

Intervention Type 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.

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

Group Type EXPERIMENTAL

different types of surgery platforms

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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20190810

Identifier Type: -

Identifier Source: org_study_id