Femoral shaft fracture is one of the major causes of mortality and morbidity. Antigrade femoral interlocking nailing is the standard treatment of femoral shaft fractures in adults. In this study the results of open and closed nailing in femoral shaft fractures are compared. This clinical trial study is performed on 40 patients with closed traumatic femoral shaft fracture without any systemic or metabolic disease. femoral shaft fracture, for the control group patients will be managed with open reduction technique whereas, for the case group patients, it is managed with closed reduction technique performed at the first week after the patients admission to the hospital.
All patients will be followed up for minimum one year after surgery and primary outcomes including the union time of fracture and infection rate will be compared between case and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203129272N1
Registration date:2012-09-22, 1391/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-22, 1391/07/01
Registrant information
Name
Javad Khajemozafari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1223 0230
Email address
mozafari@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of close versus open interlocking medulary nailing in fixation of femoral shaft fracture in adult
Public title
open and close treatment of femoral shaft fracture
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: closed femoral shaft fracture; traumatic fracture; without any systemic or metabolic disease
exclusion criteria: open fracture; pathologic fracture: multiple fracture; head trauma; viseral injury; systemic or metabolic disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Mashhad University of Medical Sciences
Street address
Central building of University, Daneshgah str., Mashhad
City
Mashhad
Postal code
Approval date
2009-03-03, 1387/12/13
Ethics committee reference number
1978138
Health conditions studied
1
Description of health condition studied
Femor fracture
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
Union
Timepoint
befor surgery, 2-4-6-8-12-16-20-24 week after surgery
Method of measurement
Radiography, Clinical examination
2
Description
osteomyelitis
Timepoint
befor surgery, 4-8-12-16 week after surgery
Method of measurement
pusy discharge in clinical examination, ESR, CRP
Secondary outcomes
1
Description
Soft callus formation
Timepoint
after surgery in 2, 4, 6, 8, 12 weekly
Method of measurement
Radiography
2
Description
Full Weight Bearing
Timepoint
after surgery: 2, 4, 6, 8, 12, 16, 20, 24 week
Method of measurement
observation
3
Description
blood transfusion
Timepoint
intra operration and during 2 week after surgery
Method of measurement
milliliter
4
Description
X ray
Timepoint
intraoperative
Method of measurement
shot
Intervention groups
1
Description
Intervention: Closed reduction of fracture
Category
Treatment - Surgery
2
Description
control: open reduction of fracture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab Hospital
Full name of responsible person
Javad Khajemozafari Dr.
Street address
Fadaieyan Eslam Avenue, Nakhrisi Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Peivandi MT.
Street address
Fadaieyan Eslam Avenue, Nakhrisi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?