Comparison of the results of fixation of Intertrochanteric fractures using Dynamic Hip Screw (DHS) and Dynamic Condylar Screw (DCS) after 6 months in patients of Aria Hospital in Mashhad in 2021-2022
Design
Single Blinded two arm parallel group randomized trial of 50 patients
Settings and conduct
Patients of Aria Hospital in Mashhad in 2021-2022
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with intertrochanteric fracture diagnosed with plain radiograph
- Patients should at least be 18 years old
Exclusion criteria:
- If needed data remains defective patients will be excluded along the study
Intervention groups
Patients above age of 18 years old with intertrochanteric fracture will be treated in 2 groups with DHS and DCS
Main outcome variables
Patients above age of 18 years old with intertrochanteric fracture will be treated in 2 groups with DHS and DCS. We'll follow up the patients in 6 months and they will be visited by an orthopedic surgeon.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220206053953N1
Registration date:2022-08-14, 1401/05/23
Registration timing:registered_while_recruiting
Last update:2022-08-14, 1401/05/23
Update count:0
Registration date
2022-08-14, 1401/05/23
Registrant information
Name
Niloofar Attarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1775
Email address
nil.at1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of fixation of Intertrochanteric fractures using Dynamic Hip Screw (DHS) and Dynamic Condylar Screw (DCS) after 6 months
Public title
Comparison of the results of fixation of Intertrochanteric fractures using Dynamic Hip Screw (DHS) and Dynamic Condylar Screw (DCS) after 6 months
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with intertrochanteric fracture diagnosed with plain radiograph
Patients should at least be 18 years old
Exclusion criteria:
If needed data remains defective patients will be excluded along the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this trial investigator is single blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of islamic azad university mashhad branch
Street address
13th floor, block A, ministry of health headquarters, Simaye Iran Ave, between South Falamak and Zarafshan, Qods Town, Tehran
City
Mashhad
Province
Razavi Khorasan
Postal code
1467674475
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.IAU.MSHD.REC.1400.108
Health conditions studied
1
Description of health condition studied
Intertrochanteric fracture of femur
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
results of fixation of Intertrochanteric fractures
Timepoint
6 months post operation
Method of measurement
Checklist - Patient records - Plain Radiograph - Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fixation of intertrochanteric fracture with DHS
Category
Treatment - Devices
2
Description
Intervention group: fixation of intertrochanteric fracture with DCS
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria Hospital
Full name of responsible person
Mohammad Mahdinejad Kashani
Street address
8th Chamran Ave, Chamran Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91378-558-14
Phone
+98 915 314 9515
Email
drmahninejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdinejad Kashani
Street address
Sarab Ave, Imam Khomeini Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91337-912-3
Phone
+98 51 3225 0041
Email
nil.at1997@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Niloofar Attarian
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdinejad Kashani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 8 Chamran Ave, Chamran Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91378-558-14
Phone
+98 915 314 9515
Email
drmahdinejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdinejad Kashani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 8 Chamran Ave, Chamran Blvd, Mashhad
City
Mashhadمش
Province
Razavi Khorasan
Postal code
91378-558-14
Phone
+98 915 314 9515
Email
drmahdinejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mehdinejad Kashani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 8 Chamran Ave, Chamran Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91378-558-14
Phone
+98 915 314 9515
Email
drmahdinejad@gmail.com
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
Undecided - It is not yet known if there will be 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