Calcaneus Fracture Clinical Trial
Official title:
A New Surgery Platform for Calcaneal Surgery: a Clinical Research
NCT number | NCT04070274 |
Other study ID # | 20190810 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | August 2019 |
Verified date | August 2019 |
Source | Yangzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yangzhou University |
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 |
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