Determination of the effect of local Erythropoietin injection on Bone union in patients with Tibiofibular fracture referring to Khatam ol Anbiya hospital in Zahedan ،2017-2018
Design
In this research, 60 eligible patients with Tibiofibular fractures referring to khatam ol Anbia Hospital in Zahedan were chosen.Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Patients are divided into two intervention and control groups. two weeks after the operation and under sterile conditions,4000 IU of EPO (two vials) were injected in intervention group into the fracture site and the control group received the equivalent of placebo.afterwards The patients were followed by
physical examination and radiographic imaging every
four weeks until union was confirmed.
Participants/Inclusion and exclusion criteria
Patients with Tibiofibular Fractures ؛Patients with Closed Fracture Type A,B؛
Fractures Caused by High Energy Trauma؛ Male Gender؛Age 18 to 40 Years
Patients with Multiple Lower Injuries, Metaphyseal and Isolated Tibial, Pathologic, Comminuted, Osteoporotic and Open Fractures
Patients under Treatment with Steroids, Anticoagulants, Nonsteroidal Antiinflammatory Drugs, Calcium Channel Blockers and Nicotine
Underlying Disease (Diabetes, Cardiovascular Disease, etc.)
Intervention groups
Intervention group: 30 patients with Tibiofibular fracture that Erythropoietin injected at the fracture site.
Control group: 30 patients with Tibiofibular fracture that used the equivalent of placebo instead of Erythropoietin.
Main outcome variables
Duration of union: The duration between of sugery and time of Bone union based on radiography and clinical examination that is based on the month.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171224038039N1
Registration date:2018-02-21, 1396/12/02
Registration timing:registered_while_recruiting
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Asma Salehi sangani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5412 3454
Email address
a.salehi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of local Erythropoietin injection on Bone union in patients with Tibiofibular fracture
Public title
The study of the effect of Erythropoietin on Bone union
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Tibiofibular fractures
Patients with closed fracture type A,B
Fractures caused by high energy of trauma
Male gender
Age between 18 to 40 years
Exclusion criteria:
Patients with multiple lower injuries, metaphyseal and isolated tibial, pathologic, comminuted, osteoporotic and open fractures
Patients under treatment with Steroids, Anticoagulants, Nonsteroidal Antiinflammatory drugs, Calcium Channel Blockers and Nicotine
Underlying disease (Diabetes, Cardiovascular disease, etc.)
Age
From 18 years old to 40 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Easy and accessible randomization , considering the entry criteria for random assignment, in an envelope, the card will be placed with the letter A, B.
then, after surgery, one of the colleagues is asked to select a card from the envelope, if A is selected, in the intervention group and if B is selected, will be placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In spite of being informed about the study, the patient is not aware of the type of intervention involved, and the injection of Erythropoietin or placebo is done by an expert who is not involved in the outcome evaluation.Therefore, the outcome evaluator is unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi sq, Pardis complex
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.ZAUMS.REC.13960228
Health conditions studied
1
Description of health condition studied
Tibiofibular fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
Duration of union: The duration between of sugery and time of Bone union was based on radiography and clinical examination that is defined based on month.
Timepoint
At the beginning of the study and every 4 weeks after surgery
Method of measurement
Physical examination and radiographic imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with Tibiofibular fracture that Erythropoietin injected at the fracture site.
Category
Treatment - Drugs
2
Description
Control group: 30 patients with Tibiofibular fracture that used the equivalent of placebo instead of Erythropoietin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Ol Anbia hospital
Full name of responsible person
Dr Arash Ghaffari
Street address
Khatam Ol Anbia hospital, Rostam Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noor Mohammad Bakhshani
Street address
Pardis Complex, Dr Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
Bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
125401-1805003
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Asma Salehi sangani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Yas Complex, Dr Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816746557
Phone
+98 51 5412 3454
Fax
Email
a.salehi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Arash Ghaffari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Khatam ol Anbia hospital, Rostam Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
Ghaffari.arash@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asma Salehi sangani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Yas Complex, Dr Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816746557
Phone
+98 51 5412 3454
Fax
Email
a.salehi@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available