Comparison of titanium elastic nail versus plate and screw fixation in diaphyseal radius and ulna fractures in 10 to 16 years old patients
Design
The number of patients in each group is 25. The patients will be randomly assigned to one of two different surgical groups using a random number table. All patients will be referred to an orthopedic clinic at two-week intervals.Goniometer measures the range of motion of the forearm and examines the rate of fracture healing using forearm radiography.
Settings and conduct
Patients enter the study according to inclusion criteria. After randomization, they will be operated on in one of the two study groups.They are then examined at specific intervals after surgery to assess forearm range and union rate.The study site is Shahid Bahonar Hospital of Kerman.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients aged 10 to 16 years with diaphyseal fractures of Radius and Ulna bones ؛ Exclusion criteria are: Diaphysis fractures of the radius and ulna bones associated with the involvement of radio ulnar joints (Montegia and Galesia)،Pathological fractures،re fracture،open fracture
Intervention groups
Investigation of the consequences and complications caused by fixing the fracture of the forearm bones such as the time of welding and the range of motion, etc. by screwing and plaque method, and examining the consequences and effects of fixing the bones of the forearm such as the time of welding and the range of motion By the method of titanium flexible rods
Main outcome variables
range of motion of fore arm after surgery & time of bone union
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200111046080N1
Registration date:2020-04-09, 1399/01/21
Registration timing:retrospective
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Reza Khosravi moshizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3216 1439
Email address
khosravireza3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of titanium elastic nail versus plate and screw fixation in diaphyseal radius and ulna fractures in 10 to 16 years old patients
Public title
comparision of two method of radius and ulna fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with radius and ulna fractures in 10 to 16 years old
Simple randomization
Personal
Patients with study characteristics are given a two-digit code. Then, using a table of random numbers, these codes are selected completely randomly, and each patient enters one of the two groups under study.
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
Campus of the University of Medical Sciences،Alavy highway،Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.KMU.AH.REC.1398.075
Health conditions studied
1
Description of health condition studied
Radius and ulna bone fractures
ICD-10 code
S52
ICD-10 code description
Unspecified fracture of forearm
Primary outcomes
1
Description
Fore arm range of motion
Timepoint
three months after surgery
Method of measurement
goniometer
2
Description
Time of union
Timepoint
6 and 10 weeks
Method of measurement
Radiographic asswsment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Fixation of diaphysis fractures of radius and ulna bones by flexible titanium rods made by Osweh Company of Mashhad
Category
Treatment - Surgery
2
Description
Intervention group2: Fixation of diaphysis fractures of radius and ulna bones by screw and plate of mini compression plates made by osweh Mashhad company
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar hospital.kerman medical university
Full name of responsible person
Reza khosravi moshizi
Street address
Shahid bahonar hospital.Gharani avn. kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3221 5011
Email
khosravireza3@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza dehnoeih
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
khosravireza3@gmail.com
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
Reza khosravi moshizi
Position
professor assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid bahonar hospital.gharani avn.kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
khosravireza3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahab illka
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid bahonar hospital.gharavi avn.kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drshahabilka@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza khosravi moshizi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
SHahid bahonar hospital.gharani avn.kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
khosravireza3@gmail.com
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
Not applicable
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