The main objective of this study is determination of alterations in serum level of inflammatory markers among patients with femoral fracture under early versus late surgery. Inclusion criteria include fracture of femoral shaft and aging from 20 to 50 years without injury to other organs and the exclusion criteria are lack of satisfaction for incorporation in the study and concomitant injuries, and chronic inflammatory diseases. Understudy population are those patients under surgery for femoral fracture which include 38 subjects in to groups 0f 19 patients. The patients would be randomly assigned to undergo either early (first 24-hour) or late (after 24 hour) surgery by block randomization method. The serum level of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha would be measured at baseline and after one hour from surgery. These will be compared across the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110519818N1
Registration date:2015-01-03, 1393/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Mehdi Moghtadaei
Name of organization / entity
Rasool Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2264
Email address
moghtadaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Alterations in serum inflammatory markers in patients under early and late surgery for femoral fractures
Public title
Inflammation in femoral fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Fracture of femoral shaft and aging from 20 to 50 years
Exclusion criteria: Presence ofconcomitant injuries, presence of chronic inflammatory diseases
Age
From 20 days old to 31 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
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
Rasool Hospital
Street address
Sattarkhan Street
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93/912
Health conditions studied
1
Description of health condition studied
Fracture of shaft of femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
Interferon Gamma
Timepoint
one hour after surgery
Method of measurement
Lab Kit
2
Description
Interleukin 1
Timepoint
one hour after surgery
Method of measurement
Lab Kit
3
Description
Interleukin 5
Timepoint
one hour after surgery
Method of measurement
Lab Kit
4
Description
Interleukin 6
Timepoint
one hour after surgery
Method of measurement
Lab Kit
5
Description
TNF-Alph
Timepoint
one hour after surgery
Method of measurement
Lab Kit
Secondary outcomes
1
Description
IL 1,5, 6 & TNF-Alpha, IFN-Gamma
Timepoint
One hour after surgery
Method of measurement
Lab Kit
Intervention groups
1
Description
Femoral Surgery
Category
Treatment - Surgery
2
Description
A group of the patients would undergo eraly surgery (before 24 hours) and in another group it will be performed as late (after 24 hours).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Hospital
Full name of responsible person
Dr. Otoukesh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Financial Department
Street address
Hemmat Exp Way, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Rasool Hspital
Full name of responsible person
Dr. Babak Otoukesh
Position
Orthopedics Surgeon
Other areas of specialty/work
Street address
Sattarkhan Street, Rasool Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+216 6516001
Fax
Email
babak_otoukesh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasool Hospital
Full name of responsible person
Babak Otoukesh
Position
Orthopedic Surgeon
Other areas of specialty/work
Street address
Sattarkhan Street, Tehran, Iran
City
Tehran
Postal code
Phone
+216 6516001
Fax
Email
babak_otoukesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasool Hospital
Full name of responsible person
Babak Otoukesh
Position
Orthopeics Surgeon
Other areas of specialty/work
Street address
Sattarkhan Street, Tehran, Iran
City
Tehran
Postal code
Phone
+216 6516001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)