Comparison of pinning treatment approach to casting in lateral condylar fractures of type 1 Homer on the range of motion of the elbow joint in children 3-10 years.
Determining and comparing the results of two therapeutic approaches of closed reduction with casting and closed placement with pinning in lateral condyle fracture of the humerus of children aged 3-10 years referred to Shahid Bahonar Educational and Medical Center in Kerman in 1401-1400
Design
This study is a clinical trial with a control group. The interventions are performed on two groups of 22 people in parallel, which are randomized and blinded in two directions. The random function of Excel software was used for randomization.
Settings and conduct
The two therapeutic approaches studied include the use of long-hand casts at 90 degrees of elbow flexion and reduction under the C-Arm and pin fixation, and the results of these two approaches will be compared.
In this study, one-way statistical analyzer has been blinded.
Participants/Inclusion and exclusion criteria
In:
Girls and boys in the age range of 3 to 10 years
Lateral condylar fractures type one
out:
Open fractures
Fractures with a higher degree
Old fractures
Dislocations and other fractures associated with type 1 fractures
Parents' dissatisfaction with the child's participation in the study
And not referring for follow-up after treatment
Intervention groups
The study units are children aged 3-10 years of both sexes with lateral condyle fracture type 1, which after obtaining informed consent from parents in a simple random method in two groups of 22 people will enter the study.
The two therapeutic approaches studied include the use of long-hand casts at 90 degrees of elbow flexion and implantation under the C-Arm device and pinning on the skin.
The control group includes the group that underwent closed reduction and casting.
Main outcome variables
Rang of motion;
Stiffness;
Infection;
Osteonecrosis;
Cubitus varus;
Bone union;
Age;
Gender.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210918052512N1
Registration date:2022-05-17, 1401/02/27
Registration timing:prospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
Registrant information
Name
Mohammad Nikukar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
mohammad.nikukar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pinning treatment approach to casting in lateral condylar fractures of type 1 Homer on the range of motion of the elbow joint in children 3-10 years.
Public title
Comparison of pinning treatment approach to casting in lateral condylar fractures of type 1 Homer on the range of motion of the elbow joint in children 3-10 years.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Girls and boys in the age range of 3 to 10 years
Lateral condylar fractures type one
Exclusion criteria:
Open fractures
Fractures with a higher degree
Old fractures
History of underlying disease
Dislocations and other fractures associated with type 1 fractures
Children outside the age range studied
Parents' dissatisfaction with the child's participation in the study
And not referring for follow-up after treatment
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are divided into two groups of 22 cases and control through simple randomization. The random feature of Excel software was used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, since blinding is not possible for physicians and patients, blinding is performed only for the analyst, so that the data of the two treatment approaches are identified with codes A and B so that it is possible to diagnose treatments for There is no analyst.
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
West First, Sixth Alley, Vahshi Bafghi Street
City
Kerman
Province
Kerman
Postal code
7613744579
Approval date
2022-04-10, 1401/01/21
Ethics committee reference number
IR.KMU.AH.REC.1401.012
Health conditions studied
1
Description of health condition studied
Lateral condyle fracture
ICD-10 code
S42.45
ICD-10 code description
Fracture of lateral condyle of humerus
Primary outcomes
1
Description
Range of motion of the elbow joint
Timepoint
two weeks
Method of measurement
Goniometer
Secondary outcomes
1
Description
Bone union
Timepoint
monthly
Method of measurement
Radiography
2
Description
Elbow joint stiffness
Timepoint
Monthly
Method of measurement
Physical examination
3
Description
Wound infection at the site of the pins
Timepoint
two weeks
Method of measurement
Physical examination
4
Description
Bone necrosis
Timepoint
Monthly
Method of measurement
Radiography
5
Description
Cubitus varus
Timepoint
Monthly
Method of measurement
Radiography
Intervention groups
1
Description
Intervention group: After Closed Reduction under C_Arm and pinning, smooth pins with a diameter of 1.5 to 2 mm will be used according to the patient's weight and age.
Category
Treatment - Surgery
2
Description
Control group: Non-surgical treatment in one group will be performed using a long cast on 90 degrees of elbow flexion in the pronation position.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Kerman
Full name of responsible person
Shahab Elka
Street address
Shahid Dr. Mohammad Javad Bahonar Hospital, Shahid Qarni St, Kerman Town
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospitalresearch@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Ahmadzadeh
Street address
Student Research Committee Headquarters, Sina Street, Jihad Boulevard, Somayeh Railway (Tahmasb Abad, Sina Street, Kerman Town
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
src@kmu.ac.ir
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
100
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
Mohammad Nikukar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital, Qarani Street
City
Kerman
Province
Kerman
Postal code
7613744579
Phone
+98 34 3223 5011
Fax
Email
mohammad.nikukar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Nikukar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital, QaraniStreet.
City
Kerman
Province
Kerman
Postal code
7613744579
Phone
+98 34 3223 5011
Fax
Email
mohammad.nikukar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Nikukar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital, Qarani Street.
City
Kerman
Province
Kerman
Postal code
7613744579
Phone
+98 34 3223 5011
Fax
Email
mohammad.nikukar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of study participants can be shared after identifying individuals. This data includes:
Therapeutic approach
Range of motion of the elbow joint
Elbow joint stiffness
Wound infection at the site of the pins
Bone necrosis
Cubitus varus
Bone burn
Age
Gender
When the data will become available and for how long
The data access period starts 6 months after the results are published.
To whom data/document is available
The text of the dissertation will be available to the public.
Access to specialized data will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The analysis of the data of this study will be possible for the people who have access to it for scientific research in university centers.
Public address for dissertation text
For scientific researchers in academic and research centers
From where data/document is obtainable
The full text of the dissertation on the digital resources website of Kerman University of Medical Sciences at https://centlib.uk.ac.ir/%D9%85%D9%86%D8%A7%D8%A8%D8%B9-%D8% AF% DB% 8C% D8% AC% DB% 8C% D8% AA% D8% A7% D9% 84 and is available on the Ganj website at https://ganj.irandoc.ac.ir.
To receive study data, correspondence with the Research Committee of Kerman University of Medical Sciences should be done at https://ksrc.kmu.ac.ir/fa.
What processes are involved for a request to access data/document
After correspondence with the research committee of Kerman University of Medical Sciences and accepting the request and confirming the data, the data will be sent to the individuals.