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A New Surgery Platform for Calcaneal Surgery: a Clinical Research

A New Surgery Platform for Calcaneal Surgery: a Clinical Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04070274
Enrollment
88
Registered
2019-08-28
Start date
2016-01-31
Completion date
2019-08-31
Last updated
2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcaneus Fracture

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.

Interventions

PROCEDUREdifferent 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.

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The whole satisfaction level of the patients and medical staffsFrom the beginning of operation till 1 days postoperativePatients 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.
The sliding frequency of the affected limb during a surgery with two methodsIntraoperativeMore or fewer times
The time patients'surgical position can last for in a surgery.IntraoperativeNecessary 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.
The frequency of the surgical instruments fall with different methodsIntraoperativeMore or fewer times

Secondary

MeasureTime frameDescription
Extra possible adverse effects due to the new surgical platformFrom the beginning of operation till 24 hours postoperativeCheck adverse effects on the basis of influences on respiratory or circulatory systems and damages on patients' nerves or skin.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026