Comparison proximal femoral nailing (PFN) versus dynamic hip screw(DHS) in intertrochanteric fracture
Design
This study clinical trial and double blind.36 patients with fetal intertrochanteric fractures who were referred to Valiasr Hospital were admitted to the study.
Settings and conduct
This study clinical trial and double blind.36 patients with fetal intertrochanteric fractures who were referred to Valiasr Hospital were admitted to the study.We divide patients in two groups randomly.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Intertrochantric fracture, aged 18 years and older, both gender, fracture less than 2 weeks, lack of multiple fractures, the absence of pathologic fracture, lack of Background Bone Disease
Exclusion criteria: lack of cooperation, fractures in children
Intervention groups
We surgery proximal femoral nailing (PFN) intertrochanteric fracture in first group and we surgery dynamic hip screw(DHS) in intertrochanteric fracture in second group.
Main outcome variables
Wound healing clinically, Improvement of fracture by radiological examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N80
Registration date:2018-06-11, 1397/03/21
Registration timing:registered_while_recruiting
Last update:2018-06-11, 1397/03/21
Update count:0
Registration date
2018-06-11, 1397/03/21
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison proximal femoral nailing (PFN) versus dynamic hip screw(DHS) in intertrochanteric fracture
Public title
Comparison proximal femoral nailing (PFN) versus dynamic hip screw(DHS) in intertrochanteric fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intertrochantric fracture
Aged 18 years and older
both gender
Fracture less than 2 weeks
Lack of multiple fractures
The absence of pathologic fracture
Lack of Background Bone Disease
Exclusion criteria:
Lack of cooperation
Fractures in children
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.
The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Individual
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Patients and surgeons are aware of the grouping. The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome elevator, and the surgeon is the real grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
15 days, one month, 3 months , 6 months and 12 months after surgery
Method of measurement
Radiological examination
3
Description
Lower limb movement
Timepoint
2, 5 and 15 day after surgery
Method of measurement
Harris hip score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We surgery proximal femoral nailing (PFN) intertrochanteric fracture.In this method, by opening the channel entrance in the central part, the fracture is fixed by manipulating the channel from the channel center into the fracture section. The fracture is kept in the depressed state
Category
Treatment - Surgery
2
Description
Intervention group: we surgery dynamic hip screw(DHS) in intertrochanteric fracture.In this method, after opening the site of operation on the DHS bed through the lateral incision, the location Determine the fracture and then set it up using proper traction and maneuver and after assurance DHS controls it with radiography in the operating room.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Amirhossein Moradi
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street