Comparison of results and complications of two trans-patellar and minimally invasive approaches in intramedullary nailing procedure in tibial fractures
1) Determining and comparing the average pain at the surgical incision site and general pain in patients undergoing intramedullary nailing in the two groups of trans Patellar and minimally invasive approaches at 1, 3, 12 and 24 weeks after surgery
2) Determining and comparing the mean range of motion of the knee in patients undergoing intramedullary nailing in the two groups of trans Patellar and minimally invasive approaches at 1, 3, 12 and 24 weeks after surgery
3) Determining and comparing the frequency of knee hematoma in patients undergoing intramedullary nailing in two groups of trans Patellar and minimally invasive approaches at 1, 3, 12 and 24 weeks after surgery
4) Determining and comparing the average size of the tibial protrusion in the patients undergoing intramedullary nailing in the two groups of trans Patellar and minimally invasive after surgery
Design
Clinical trial with control group, with parallel groups, with blinded, randomized, on 122 patients. Excel software rand function was used for randomization.
Settings and conduct
The study was performed on patients with tibial fracture and hospitalized in Alzahra and Kashani hospitals of Isfahan by the orthopedic system of these hospitals. due to the incision site after surgery, it is not possible for the patient and the follow-up assistant to be blinded. But the one who does the statistical analysis is blind to assigning groups.
Participants/Inclusion and exclusion criteria
entry:
20-40 years
Tibial fracture
Not entry:
Immunodeficiency
Diabetes
Malnutrition
Multiple Trauma
Dirty Wounds and Gastillo Type 3
Intervention groups
Evaluation of 2 surgical methods in tibial fracture
Main outcome variables
Determining the superiority of the selective approach to tibial Intramedullary nailing; Determining the complications of selective approaches in tibial intramedullary nailing.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049176N1
Registration date:2020-11-19, 1399/08/29
Registration timing:registered_while_recruiting
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
hamid mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3779 1559
Email address
hamidmehrabi67@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-08, 1399/06/18
Expected recruitment end date
2020-12-08, 1399/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results and complications of two trans-patellar and minimally invasive approaches in intramedullary nailing procedure in tibial fractures
Public title
Evaluation of 2 surgical methods in tibial fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Close or open fracture of tibia gastillo type 1 and 2
Indication of intermedullary nailing, which was determined by 2 professors
Close reduction is done and fixation with intermedullary nail
Exclusion criteria:
Immunodeficiency
Diabetes
Malnutrition with albumin below 3.5 and BMI less than 18
multiple trauma
Dirty Gastillo Type 3 Wounds
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
According to the random code provided by the software to the executor of the project and printed on a sheet and in sealed envelopes, the patient number is assigned to him.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that the incision site is visible after surgery, it is not possible for the patient and the follow-up assistant to blind. But the one who does the statistical analysis is blind to assigning groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Unit 4, 6-unit apartment, South side of the park, Yarmohammadian Alley, Allameh Jafari St, Rudaki Street
City
Isfahan
Province
Isfehan
Postal code
8176963935
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.MUI.MED.REC.1399.461
Health conditions studied
1
Description of health condition studied
tibial fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incisional pain and general postoperative pain and restricted postoperative knee movement and postoperative knee hematoma
Timepoint
Evaluation of pain and hematoma and restriction of knee movement at 1, 3, 12 and 24 weeks after surgery
Method of measurement
Visual Analogue Scale; physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Minimally invasive surgical approach to intramedullary nailing in tibial fractures
Category
Treatment - Surgery
2
Description
Control group: Parapatellar surgical approach to intramedullary nailing in tibial fractures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra and Kashani hospital
Full name of responsible person
Hamid mehrabi
Street address
Unit 4, 6-unit apartment, South side of the park, Yarmohammadian Alley, Allameh Jafari St, Rudaki Street
City
Isfahan
Province
Isfehan
Postal code
8176963935
Phone
+98 31 3779 1559
Email
hamidmehrabi67@resident.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid mehrabi
Street address
Unit 4, 6-unit apartment, South side of the park, Yarmohammadian Alley, Allameh Jafari St, Rudaki Street
City
Isfahan
Province
Isfehan
Postal code
8176963935
Phone
+98 31 3779 1559
Email
hamidmehrabi67@resident.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamid mehrabi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Unit 4, 6-unit apartment, South side of the park, Yarmohammadian Alley, Allameh Jafari St, Rudaki Street
City
Isfahan
Province
Isfehan
Postal code
8176963935
Phone
+98 31 3779 1559
Email
hamidmehrabi67@resident.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid mehrabi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Unit 4, 6-unit apartment, South side of the park, Yarmohammadian Alley, Allameh Jafari St, Rudaki Street
City
Isfahan
Province
Isfehan
Postal code
8176963935
Phone
+98 31 3779 1559
Email
hamidmehrabi67@resident.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid mehrabi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
خ رودکی خ علامه جعفری کوی یارمحمدیان ضلع جنوبی پارک آپارتمان 6 واحدی واحد 4
City
Isfahan
Province
Isfehan
Postal code
8176963935
Phone
+98 31 3779 1559
Email
hamidmehrabi67@resident.mui.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
Yes - There is a plan to make this available
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to expand studies and improve patients' health
From where data/document is obtainable
hamidmehrabi67@resident.mui.ac.ir
What processes are involved for a request to access data/document