To study two treatment methods, "closed reduction and external fixation with pin" and "opened reduction and internal reduction" in Supracondylar fractures.
90 patients, under 10 years old, with Supracondylar fracture in Ayatollah Kashani hospital, Sharekord, Iran, are selected and randomly allocated in two groups according to the methods. The time of operation, radiography, wound infection, treatment cost and the rate of movement area for elbow are compared between two groups in the eighth week after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105146480N1
Registration date:2011-06-11, 1390/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord university of medical sciences
Expected recruitment start date
2011-05-30, 1390/03/09
Expected recruitment end date
2011-12-28, 1390/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two surgery methods for treatment of supracondylar fracture in children under 10 years old in Ayatollah Kashani hospital
Public title
The comparison of two surgery methods for treatment of supracondylar fracture in children under 10 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: satisfaction of the parents, age below the 10 years. Exclusion criteria: background diseases, head trauma, taking more than 5 days from the day of fracture.
Age
To 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shahrekord university of medical sciences
Street address
Kashani Blvrd
City
Shahrekord
Postal code
Approval date
2009-06-05, 1388/03/15
Ethics committee reference number
88-13-2
Health conditions studied
1
Description of health condition studied
supracondylar fracture
ICD-10 code
M90
ICD-10 code description
Osteopathies in diseases classified elsewhere
Primary outcomes
1
Description
infection
Timepoint
1 week
Method of measurement
physical exam
2
Description
operation duration
Timepoint
post operation
Method of measurement
duration in minute
3
Description
skiagraphy checking
Timepoint
every week
Method of measurement
skiagraphy
Secondary outcomes
1
Description
elbow joint movement range
Timepoint
8 week of operation
Method of measurement
Maximum angle of motion
Intervention groups
1
Description
placing the packet and pinning off the skin
Category
Treatment - Surgery
2
Description
opened reduction and internal fixation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr. Dehghan
Street address
Kashani avenue
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord university of medical sciences
Full name of responsible person
Dr. Mahmoud Mobasheri
Street address
Kashani blvrd
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord 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
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Morteza Dehghani
Position
Assistant Professor
Other areas of specialty/work
Street address
Orthopaedy Department, Kashani hospital
City
Shahrekord
Postal code
Phone
+98 913 183 2044
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Morteza Dehghan
Position
Orthopedist
Other areas of specialty/work
Street address
Orthopaedy Department, Kashani Hospital
City
Shahrekord
Postal code
Phone
+98 913 183 2044
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)