Determining and comparing of the effects two methods manual traction and automatic traction in femural fractures surgery
Design
Adults between 18 and 35 years old candidate for femoral fracture plate surgery
Sample including a 10% increase in terms of the probability of loss, 65 people were
Sampling will be performed using available non-probabilistic sampling
Settings and conduct
Shahid Bahonar and Shafa hospitals affiliated to Kerman University of Medical Sciences
The first group will include patients who undergo femoral fracture plate surgery in the orthopedic ward of Shahid Bahonar and Shafa hospitals in Kerman and the traction in them is performed manually by the surgeon. The second group also includes patients who are in the period. The same fracture will be inserted by automatic traction method.
Participants/Inclusion and exclusion criteria
Need for femoral plate surgery؛No infection before surgery؛No bleeding diseases؛Do not have any abnormalities in coagulation tests؛No mental retardation؛Lack of chronic underlying diseases (diabetes, cancer, etc.).
Intervention groups
The control group will include patients who undergo plaque surgery to treat femoral fractures, and traction in this Patients are performed manually by a surgical technologist. In this way, using 2 bone clamps, these two pieces of fracture are placed next to each other manually and with a lot of force by the surgical technologist.The intervention group includes patients whose fractures will be implanted by automatic traction method. Automatic traction is a new tool developed by the researcher of this project This tool performs traction during surgery regularly and continuously and requires additional personnel in Removes the surgical field.
Main outcome variables
The aim of the trial here is to investigate the effect of manual and automatic traction intervention on pain, fatigue and duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049987N1
Registration date:2021-02-13, 1399/11/25
Registration timing:prospective
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
ّFarzad Abaszadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 1539
Email address
f.abaszadeh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects two methods manual traction and automatic traction in femural fractures surgery
Public title
Comparison of the effects two methods manual traction and automatic traction in femural fractures surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need for femoral plate surgery
Exclusion criteria:
infection before surgery
bleeding diseases
any disturbance in coagulation tests
mental retardation
chronic underlying diseases (diabetes, cancer, etc.)
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Postal Code: 7616913555
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
IR.KMU.REC.1399.546
Health conditions studied
1
Description of health condition studied
femural fractures surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in McGill Questionnaire
Timepoint
After surgery
Method of measurement
.McGill Pain Questionnaire
2
Description
The duration of surgery is calculated based on minutes according to the surgery
Timepoint
The duration of surgery is measured in minutes from the moment the surgeon declares the need for traction until the two broken pieces are placed side by side.
Method of measurement
Based on minutes spent using the clock at the surgery site
3
Description
The amount of musculoskeletal pain and discomfort based on the score obtained from the Nordic questionnaire
Timepoint
After surgery
Method of measurement
Nordic Ergonomics Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : The intervention group includes patients whose fractures will be implanted in the same period of time by automatic traction method. Automatic traction (use in the femur) is a new tool developed by the researcher of this project (Patent application number: 139850140003002894 Patent number: 100601.) This tool performs traction during surgery regularly and continuously and requires additional personnel in Removes the surgical field.The holder plate of this device has 2 bases and each of these bases is connected to a circular ring that these rings have the ability to increase and decrease the diameter so that they can fit The patient's femur becomes large or small, and these rings have grooved sections that are necessary for fixation to the patient's bone
Category
Treatment - Surgery
2
Description
Control group: The control group will include patients who undergo plaque surgery in the orthopedic ward of Shahid Bahonar and Shafa hospitals in Kerman to treat femoral fractures, and traction (how to place separate bones next to each other) in this Patients are performed manually (traditional and common) by a surgical technologist. In this way, using 2 bone clamps (orthopedic tools), these two pieces of fracture are placed next to each other manually and with a lot of force by the surgical technologist, and then the surgeon fixes the plaque in the desired area with screws
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar and Shafa hospitals affiliated to Kerman University of Medical Sciences
Full name of responsible person
Farzad Abaszadeh
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
fabaszadeh99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhty, Vice Chancellor of Research and technologyKerman University of Medical Sciences
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
postal code :7619813
Phone
+98 34 3132 5700
Email
KMU_RESEARCH@YAHOO.COM
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzad Abaszadeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 4196
Email
fabaszadeh99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzad Abaszadeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 4196
Email
fabaszadeh99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzad Abaszadeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 4196
Email
fabaszadeh99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic institutions and people working in industry
Under which criteria data/document could be used
No special mechanism is required
From where data/document is obtainable
fabaszadeh99@gmail.com
What processes are involved for a request to access data/document
No special mechanism is required
fabaszadeh99@gmail.com