Determination the postoperative results in two methods of Dynamic hip screw and Dynamic external fixator in intertrochantric fractures.
Design
Clinical trial; Have control group; each group - 15 patients; Randomized.
Settings and conduct
Patients with intertrochanteric fracture and having conditions in the plan are randomly assigned to one of two groups.In Dynami hip screw(DHS), from side plate with 2 to 4 hole and in Dynamic external fixator two Shanz in the neck of the femur and three in the distal femoral shaft are embedded. Fractures in terms of fracture type and level of osteoporosis, and the rate of complications are compared in two types of fixation.Follow-up will be at least six months.
Participants/Inclusion and exclusion criteria
male or female patients with intertrochantric fractures.
Inclusion: Age over 65، fracture of type A1 or A2، one density less than 2.5 in T Score، Ability to walk without help before fracture, Patients at risk of anesthesia III and IV.
non inclusion: Previous hip fracturet, Secondary fracture to the tumor, Soft tissue or bone infection in the area, Chemotherapy, Fracture simultaneously in another area.
Intervention groups
Intervention group 1: 15 patients with intertrochantric fracture and using a new external fixator device
Intervention group 2: 15 Patients with intertrochantric fracture and using internal fixator
Main outcome variables
The amount of hematocrit of the blood, Haspitalization, Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181015041344N1
Registration date:2019-05-24, 1398/03/03
Registration timing:retrospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Meisam Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 6122
Email address
moradim941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of Dynamic hip screw and Dynamic external fixator in intertrochantric fractures.
Public title
Comparison of Dynamic hip screw and Dynamic external fixator in intertrochantric fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intertrochantric fracture of type A1 or A2
Age over 65 years old
Bone density less than 2.5 in T score
The patient was able to walk without help before the fracture.
The patient should be at high anesthetic risk
Exclusion criteria:
Previous hip fracture
Secondary fracture to the tumor
Soft tissue or bone infection in the area
Chemotherapy
Simultaneous fracture In the other area
Age
From 65 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)
Randomized
Randomization description
Simple randomization method was performed using a random number table.
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
Ethical Committe of Mashhad University of Medical Sciences
Street address
Ghoreishi Department, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
IR.MUMS.REC.1395.580
Health conditions studied
1
Description of health condition studied
Comparison of the results of two surgical methods in Treatment Intertrochanteric fracture.
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
pain
Timepoint
before intervention and 6 days after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The amount of hematocrit of the blood
Timepoint
before and after intervention
Method of measurement
the blood test
2
Description
Haspitalization
Timepoint
after intervention
Method of measurement
the day number of hospitalization
Intervention groups
1
Description
Intervention group: The use of Dynamic external fixator in patients with intertrochantric fractures
Category
Treatment - Devices
2
Description
Control group: The use of Dynamic hip Screw in patients with intertrochantric fractures
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Farshid Bagheri
Street address
Research Center, Imam Reza Hospital, Imam Reza square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
051-9137913316
Phone
+98 51 3853 8659
Fax
+98 51 3859 1057
Email
MoradiM941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91666-37477
Phone
+98 51 3843 3363
Fax
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Moradi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Research Center, Imam Reza Hospital, Imam Reza square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3853 8659
Fax
+98 51 3859 1057
Email
MoradiAL@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Meysam Moradi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ahmadabad Street, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2610
Fax
+98 51 3854 9234
Email
moradia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Meisam Moradi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Orthopedic Research Center, Shahid Kamyab Hospital, Fadaeian Eslam Street, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91666-37477
Phone
+98 51 3802 6122
Fax
+98 51 3854 9234
Email
MoradiM941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
These data are very specialized and not applicable to the public, and their publication is not obligatory from the authors' point of view.
When the data will become available and for how long
After completing the clinical trial
To whom data/document is available
Orthopeadics
Under which criteria data/document could be used
In order to increase the knowledge and use of new instrument in surgical procedures, after completing the clinical trial and publication of the article can be used.
From where data/document is obtainable
Apply to the email of Dr. Meisam Moradi.
What processes are involved for a request to access data/document
The request has been sent to Dr. Maysam Moradi's email and after being reviewed by him, if necessary, the email will be sent to the person.