Compare of clinical outcomes of three type of surgery techniques including gamma locking nail, Dynamic Hip Screw (DHS) and Bipolar Hemiarthroplasty in unstable intertrochanteric fracture
Design
30 , unrandomise
Settings and conduct
The study selected 30 patients referred to Taleghani Hospital in 1394-1395 years. treatment outcomes: patients should be able to walk independently before the fracture to be chosen for study. Patients are examined after an average follow-up of 6 months by the means of functional rate(HHS) and imaging methods.
Participants/Inclusion and exclusion criteria
The study selected 30 patients (Both genders with age > 60 yr) with unstable intertrochanteric fracture according to AO/ota classification(31-Aَ3), referred to Taleghani Hospital in 1394-1395 years, . Patients should be able to walk independently before the fracture to be chosen for study.To prevent the distortion of information, the fractures should notbe pathological type and the patient didn’t haveany previous fracture at the hip
all included cases underwent bipolar hemi arthroplasty with distal fit long stem
Intervention groups
Unstable interthrocanthric fracture treated by primary hemiarthroplasty with long stem distal fitted
Main outcome variables
Time of surgery; bleeding; harris hip score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039188N1
Registration date:2018-05-07, 1397/02/17
Registration timing:retrospective
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Reza Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
reza.zandi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-04-21, 1396/02/01
Trial completion date
empty
Scientific title
Evaluation of Primary bipolar hemiarthroplasty with distally fixed long stem outcome for unstable intertrochanteric femural fractures in elderly
Public title
Evaluation of Primary bipolar hemiarthroplasty with distally fixed long stem outcome for unstable intertrochanteric femural fractures in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unstable intertrochanteric fracture;
Both gender;
Patients should be able to walk independently before the fracture to be chosen for study;
fractures should not be pathological;
no previous fracture at the hip.
Exclusion criteria:
stable fracture
disable to walking
pathologic fracture
pervious hip fracture
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran,Velenjak,Yaman st,taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.109
Health conditions studied
1
Description of health condition studied
intertrochanteric fracture
ICD-10 code
S72.14
ICD-10 code description
Intertrochanteric fracture of femur
Primary outcomes
1
Description
improvement of treatment quality
Timepoint
After 2 months and 6 months and 1 year of treatment
Method of measurement
questionnaire and. hip radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fixation with distal fit prothesis
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Reza Zandi
Street address
Velenjak of Tehran, Taleghani hospital of Erabi st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
reza.zandi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Street address
building 2, Shahid Beheshti University,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2387 2206
Email
reza.zandi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9937
Email
Reza.zandi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza zandi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9937
Email
Reza.zandi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9937
Email
Reza.zandi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
no information
When the data will become available and for how long
don't choice yet
To whom data/document is available
don't choice yet
Under which criteria data/document could be used
don't choice yet
From where data/document is obtainable
don't choice yet
What processes are involved for a request to access data/document