Comparison of two methods of Fixation with a Plaque and Functional brace in The treatment of Humerus trunk fracture in Patients referred to Bahonar Hospital
Due to the high prevalence of Humerus fractures and dysfunction in patients with fractures and disagreement about the appropriate treatment method concerning the advantages and disadvantages of each surgical and non-surgical method in this study, the intention to achieve a standard method with high efficiency, time We have less treatment and shorter recovery in patients with Humerus trunk fractures.
Design
Divide patients into two groups and perform surgical intervention on one group and follow the other group with functional braces.
Settings and conduct
People who complain of Humerus shaft fracture to the emergency department of Shahid Bahonar Hospital in Kerman, are divided into two groups to assign people to two the group uses block randomization, one group is referred to the operating room and after the initial procedures, it is operated by sterile method and fixation with plaque is performed for them. The other group They are followed up in the emergency room by uslap and are discharged after one day with Sarminto functional brace.
Participants/Inclusion and exclusion criteria
Inclusion criteria include people 18 to 60 years of age, including adults with informed and written consent; Criteria for not including people below 18 or over 60 years old; patients with open wounds at the fracture site; patients with neurological involvement; patients with a history of previous surgery at the fracture site; people with multiple injuries, people with Multiple fractures and people who do not have conscious consent.
Intervention groups
Patients who have undergone sterile surgery and for whom a plaque is fixed; The next group of patients who are followed up using functional braces.
Main outcome variables
According to the results of this trial, we have achieved a preferred method that can optimize the treatment method, treatment cost, duration and quality of treatment for us.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052152N1
Registration date:2021-09-30, 1400/07/08
Registration timing:registered_while_recruiting
Last update:2021-09-30, 1400/07/08
Update count:0
Registration date
2021-09-30, 1400/07/08
Registrant information
Name
Ali Bahador
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3321 1291
Email address
aliba1392@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of Fixation with a Plaque and Functional brace in The treatment of Humerus trunk fracture in Patients referred to Bahonar Hospital
Public title
Comparison of "Humerus fusion, in surgical methods with non-surgical methods"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes people 18 to 60 years old who are adults
Includes people who have informed and written consent
Exclusion criteria:
Patients below18 or over 60
Patients with open wounds at the fracture site
Patients with neurological involvement
Patients with a history of previous surgery at the same fracture site
Patients with multiple injuries and fractures
patients who don't have informed consent
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Doctor blvd. Daneshvar st.
City
Kerman
Province
Kerman
Postal code
7617735845
Approval date
2021-07-12, 1400/04/21
Ethics committee reference number
IR.KMU.REC.1400.224
Health conditions studied
1
Description of health condition studied
Humerus shaft fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Formation of bone callus correctly and in the required amount that does not lead to a change in the schematic of the bone, and in normal time, welding and formation of bone callus that can provide activities similar to the patient's previous activities.
Timepoint
The two groups are examined in weeks 0-2-4-12-24 and also during the visits, the patient is radiographed and examined for bone formation at the fracture site. Also, the patient is followed up by telephone for three months.
Method of measurement
Observation of bone callus at the fracture site using bone radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group is referred to the operating room and after the initial procedures, it is operated by sterile method and fixation with plaque is performed for them.
Category
Treatment - Surgery
2
Description
Intervention group: The second intervention group is followed by uslap in the emergency room and after one day They are discharged with functional Sarminto braces
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Kerman
Full name of responsible person
Ali Bahador
Street address
Qaraney st.
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
Ali Bahador
Street address
The beginning of Haft Bagh Blvd. Campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5855
Email
international@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
Ali Bahador
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Doctor blvd. Daneshvar st.
City
Kerman
Province
Kerman
Postal code
7617735845
Phone
+98 34 3321 1291
Email
aliba1392@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Bahador
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Doctor Blvd. Daneshvar St.
City
کرمان
Province
Kerman
Postal code
7617735845
Phone
+98 34 3321 1291
Fax
Email
aliba1392@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Bahador
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Doctor Blvd. Daneshvar St.
City
کرمان
Province
Kerman
Postal code
7617735845
Phone
+98 34 3321 1291
Fax
Email
aliba1392@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
All data received from the subjects after the unidentifiable individuals can be shared, including the type of fracture, the location of the fracture, the type of intervention and the outcome of the intervention.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Allow access to researchers and academic centers
Under which criteria data/document could be used
Access to the data is allowed with the permission of the university for conducting clinical research and use to choose the treatment method
From where data/document is obtainable
Dr. Amir Reza Sadeghifar 09123377411 Dr. Ali Bahador 09135011190
What processes are involved for a request to access data/document
After writing the required letter of data and confirmation of the school of origin and the school of destination and a copy of the letter to the mentioned people, after reviewing the information will be sent to the school of destination in a confidential letter. It should be noted that this process takes at least two months.