Comparison of Titanium Elastic Nail (TEN) application for fixation of femoral trunk fractures in children with medial and lateral or just lateral portal
Comparison of Titanium Elastic Nail (TEN) application for fixation of femoral trunk fractures in children with medial and lateral or just lateral portal
Design
This study is a randomized (simple random) and single-blind clinical trial with parallel groups and in phase 2-3 that will be performed in Shohada Hospital in Tabriz.
Settings and conduct
This clinical trial study will be performed in Shohada Hospital of Tabriz with the participation of 40 children with femoral trunk fractures. Patients will be blind during this study. Patients will be divided into two groups after randomization (dice roll); for one group, TEN will be operated with lateral portal and the other with TEN with two medial and lateral portals.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: unilateral or bilateral femoral trunk fracture and age range of 5 to 16 years and exclusion criteria also include: patients with open femoral fracture.
Intervention groups
In this randomized, single-blind clinical trial study, 40 patients were divided into two groups of 20 patients. For the first group, using TEN with lateral portal and the second group with TEN with two medial and lateral portals will be operated.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161101030637N3
Registration date:2021-11-04, 1400/08/13
Registration timing:prospective
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
hossein aslani
Name of organization / entity
tabriz university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 41 3389 3765
Email address
aslanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Titanium Elastic Nail (TEN) application for fixation of femoral trunk fractures in children with medial and lateral or just lateral portal
Public title
TEN application for fixation of femoral trunk fractures in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or bilateral femoral trunk fracture
Age range 5 to 16 years
Exclusion criteria:
Patients with open femoral fractures
Age
From 5 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized (simple random) and single-blind clinical trial with parallel groups and in phase 2-3 that will be performed in Shohada Hospital in Tabriz.It should be noted that patients will be unaware of the type of groupings and randomly (dice roll was used for simple randomization. For patients in the first intervention group, odd numbers were considered and for patients in the second group, even numbers in Were considered) were divided into two groups .
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients studied in this study will be unaware of the type of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Azadi Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.TBZMED.REC.1399.1064
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain
Timepoint
Three times a day for a week
Method of measurement
Visual scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will have surgery using Titanium Elastic Nail (TEN ) with lateral portal femoral trunk fracture and will be examined for one week from the release of pain intensity (three times a day)
Category
Treatment - Devices
2
Description
Intervention group: Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will be operated on using TEN with two medial and lateral portals of their femoral bone fracture and for one week from the release of pain intensity (three times a day). ) Will be checked.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Hossein Aslani
Street address
Golshahr Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 3982
Email
Dr.aslani73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiie
Street address
Azadi Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 3982
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Aslani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 3982
Email
Dr.aslani73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Aslani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 3982
Email
Dr.aslani73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Aslani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 3982
Email
Dr.aslani73@yahoo.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