Comparison of changes in inflammatory factors in patients with intertrochanteric femoral fracture treated with Dynamic Hip Screw surgery with intramedullary nailing
The aim of study was to evaluate inflammatory factors in patients with intertrochanteric femoral fracture treated with dynamic hip screw surgery with intramedullary nailing.
Design
The design of study is a parallel that will be performed with the structure of a three phase clinical trial. In this study, 180 patients will be assigned to surgical groups by dynamic hip screw and intramedullary nailing methods by block randomization. There is no blinding in this study because patients, surgeons, and study outcome assessors are aware of the type of study groups. Randomization will be done using Random Allocation software the blocks will be identified randomly and the groups with the letters A and B.
Settings and conduct
This study was designed to evaluate inflammatory factors in patients undergoing orthopedic surgery due to intertrochanteric femoral fracture. Patients will be selected by considering the inclusion and non-inclusion criteria from the orthopedic ward of Moheb and Rasoul Akram hospitals in Tehran. Then, by block randomization method, we will assign 180 patients to groups with dynamic hip screw and intramedullary nailing surgery.
Participants/Inclusion and exclusion criteria
The criteria considered for the study were confirmed intertrochanteric femoral fracture and age over 18 years. If there are other fractures, the person will not be included in the study.
Intervention groups
Patients in the intervention group will be operated using dynamic hip screw method and patients in the control group will be operated using intramedullary nailing method.
Comparison of changes in inflammatory factors in patients with intertrochanteric femoral fracture treated with Dynamic Hip Screw surgery with intramedullary nailing
Public title
Comparison of inflammatory factors in Dynamic Hip Screw surgery with intramedullary nailing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed intertrochanteric fracture of the femur
Over 18 years old
Exclusion criteria:
Having other fractures
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants in the study using inclusion and non-inclusion criteria, to prevent the occurrence of bias in the selection of participants to intervention and control groups, we will use the randomization method to minimize the opinion of researchers in selecting participant to study groups. The block randomization method was used in this study. The size of the blocks is considered to be four and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A and B. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output.
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
Ethics committee of Iran university of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.IUMS.REC.1399.1187
Health conditions studied
1
Description of health condition studied
Femoral fracture
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
Serum Level of C-Reactive Protein
Timepoint
One hour before and 24 hours after surgery
Method of measurement
level of serum CRP with Elisa assay
2
Description
Serum Level of Interleukin 6
Timepoint
One hour before and 24 hours after surgery
Method of measurement
level of serum interleukin 6 with Elisa assay
3
Description
Serum level of Tumor Necrosis Factor alpha
Timepoint
One hour before and 24 hours after surgery
Method of measurement
level of serum TNF-α with Elisa assay
Secondary outcomes
1
Description
Nonunion fractures
Timepoint
One month after surgery
Method of measurement
Radiological imaging
Intervention groups
1
Description
Intervention group: Surgery by Dynamic Hip Screw method
Category
Treatment - Surgery
2
Description
Control group: Surgery by Intramedullary nailing method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Ali Yeganeh
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Email
yeganeh.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motavalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sahand Cheraghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Email
sahandchera5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Email
yeganeh.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sahand Cheraghi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Email
sahandchera5@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
No - There is not 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