Comparison of the use of bone stabilizer and non-use of bone stabilizer for bone fracture in patients with bone fracture to accelerate and improve surgery.
Comparison of the use of bone stabilizer and non-use of bone stabilizer for bone fracture in patients with bone fracture to accelerate and improve surgery.
Design
In this study, patients with high bone fracture are divided into two groups of control and intervention. In this study, the participants do not know how to allocate to the group and the study is one-way blind. The number of participants in the study is 5 in each group. The method of assigning people in each group is non-random. . Intervention group: In this group, bone stabilization is used during surgery Control group: In this group, bone stabilizer is not used during surgery.This study is conducted in 2019. The phase of the clinical trial is 1-2.
Settings and conduct
This study is carried out at Arak University of Medical Sciences in Vali Asr . Patients referred to this center who have long bone fractures are divided into two groups of control and intervention. In this study, participants were blind and unaware of the use of stabilizers and their lack of use.
Participants/Inclusion and exclusion criteria
Having a long bone fracture
Intervention groups
Intervention group: In this group, bone stabilization is used during surgery
Control group: In this group, bone stabilizer is not used during surgery
Main outcome variables
Disruptions during the Dream
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190113042338N1
Registration date:2019-06-16, 1398/03/26
Registration timing:registered_while_recruiting
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Hamed Rohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3504
Email address
hamedrohi5304@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-31, 1397/11/11
Expected recruitment end date
2019-06-24, 1398/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the use of bone stabilizer and non-use of bone stabilizer for bone fracture in patients with bone fracture to accelerate and improve surgery.
Public title
Investigating the use of bone stabilizer in bone fracture surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Fracture of tall bones of the leg
Bone fracture is less than two days
Fractures at one point of each tall bone
Satisfaction to enter the study
Exclusion criteria:
Complete bone fracture
Small bone fracture
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
5
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is unaware of the type of division in the groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7-6941
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.ARAKMU.REC.1397.236
Health conditions studied
1
Description of health condition studied
Fracher tall bone
ICD-10 code
M48.5 Coll
ICD-10 code description
XIII Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Disruptions during the Dream
Timepoint
A week later of intervention
Method of measurement
Self-made questionnaire
Secondary outcomes
1
Description
Surgeon satisfaction in using the fixator and lack of use of the fixator
Timepoint
After surgery
Method of measurement
Questionnaire
2
Description
Satisfaction or dissatisfaction of the patient with the operation in two groups
Timepoint
A week later
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In this group, bone stabilization is used during surgery. This stabilizer fixes during the operation on the bone, which prevents bone movement during drills and surgery, instead of human labor.
Category
Treatment - Devices
2
Description
Control group: In this group, bone stabilizer is not used during surgery. In these patients, the stabilizer is not used during bone surgery, and instead of manpower is used to fix the bone during drill and surgery.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Medical Education Center, Arak, Iran
Full name of responsible person
Hamed Roohi
Street address
Basij square
City
ARAK
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3504
Fax
+98 56 3417 3524
Email
hamedrohi5304@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmand Zadegan
Street address
Basij square
City
ARAK
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3504
Fax
+98 86 3417 3521
Email
mmatinam81@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamed Rohi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij square
City
ARAK
Province
Markazi
Postal code
3848176941
Phone
008986341735.4
Email
hamedrohi5304@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamed Rohi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij square
City
ARAK
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3504
Email
hamedrohi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamed Rohi
Position
stident
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij square
City
ARAk
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3504
Email
hamedrohi@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
Not applicable
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potential data can be shared after being unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
For all who are in the medical group
Under which criteria data/document could be used
There are no specific conditions for access
From where data/document is obtainable
They can use the publication
What processes are involved for a request to access data/document