The principle goal of the present study is the comparison of open and closed reduction and fixation in supracondylar humeral fracture in children. This is a randomized clinical trial. The sample includes 50 children, age range 3-10 years with supracondylar humeral fractures in an 18 month period, in Shohada orthopedic centre, Tabriz, Iran. They will undergo open or closed reduction and be followed for 3 month. Control radiologic imaging will be performed in 3 episodes, post operation, 2 week and 3 month later to evaluate carrying angle changes while considering cosmetic and functional outcomes and limitation of elbow joint in both groups. The main outcome to be assessed is the carrying angle. The supracondylar humeral fracture is the main inclusion criteria in this study and additional fractures and open fracture will be considered as exclusion criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904244381N1
Registration date:2011-04-30, 1390/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-30, 1390/02/10
Registrant information
Name
Niloofar Esmaeli
Name of organization / entity
Tabriz university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 7080
Email address
ganjpourj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of closed and open reduction & fixation of supracondylar fractures of humerus in children
Public title
Comparison of closed and open reduction & fixation of supracondylar fractures of humerus in children
Purpose
Treatment
Inclusion/Exclusion criteria
The supracondylar humeral fracture is the main inclusion criteria in this study and additional fractures and open fracture will be considered as exclusion criteria.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht st
City
Tabriz
Postal code
Approval date
2009-12-21, 1388/09/30
Ethics committee reference number
8913
Health conditions studied
1
Description of health condition studied
Supracondylar Fracture Of Humerous
ICD-10 code
S42
ICD-10 code description
Fracture of shoulder and upper arm
Primary outcomes
1
Description
Carring Angle
Timepoint
In three Episodes, 1- Post operation 2-two weeks later 3-three months later
Method of measurement
Ruler And Protractor
Secondary outcomes
1
Description
Casmetic and functional outcores
Timepoint
In three Episodes, 1-post opreation 2- two weeks latear 3-three months later
Method of measurement
clinical
Intervention groups
1
Description
open surgical reduction
Category
Treatment - Surgery
2
Description
closed reduction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Educational Center
Full name of responsible person
Dr. Ganjpour
Street address
Elgoli
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ganjpour
Street address
Shohada Educational Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Niloofar Esmaile
Position
PhD Student
Other areas of specialty/work
Street address
Education Center Shohada, Elgoli
City
Tabriz
Postal code
Phone
+98 41 1332 7080
Fax
Email
niloofar_ek@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ganjpour sales
Position
Assistant Professor
Other areas of specialty/work
Street address
Education Center Of Shohada, Elgoli
City
Tabriz
Postal code
Phone
+98 41 1385 9314
Fax
Email
ganjpourj@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Niloofar Esmaile
Position
PhD Student
Other areas of specialty/work
Street address
Educational Center Shohada, Elgoli
City
Tabriz
Postal code
Phone
+98 41 1332 7080
Fax
Email
niloofar_ek@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)