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Comparison of Outcomes of Tibial Shaft Fractures Treated by Dynamic Compression Plate and Intramedullary Nail

Protocol summary

Study aim
Comparison of Outcomes of Tibial Shaft Fractures Treated by Dynamic Compression Plate and Intramedullary Nail
Design
Clinical trial with control group, with parallel groups, randomized, on 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this double-blind clinical trial study, all patients who undergo orthopedic surgery at Shahid Beheshti Hospital in Babol are included in the study.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: age 15 to 65 years, fracture following acute trauma, the presence of a fracture in the diaphysis of the tibia, and having consent to enter the study, and the exclusion criteria include: a history of tibial bone fracture in two lower limbs. , previous non-union, open fracture, history of underlying bone disease, history of tibial bone fracture in two lower limbs, peroneal nerve damage, accompanied by proximal or distal fracture.
Intervention groups
The first group is operated by Nile's intramedullary method, where the rods are made by Oswe company and are made of steel. The second group is done by the Dynamic Compression Plate method, fixing the bone with AO dynamic compression plate made by Oswe company, with at least 8 narrow holes.
Main outcome variables
Milionion, non-union, delayed union, pain, tenderness, infection of the operation area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221029056333N2
Registration date: 2023-01-23, 1401/11/03
Registration timing: registered_while_recruiting

Last update: 2023-01-23, 1401/11/03
Update count: 0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Mehdi Tavasoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.tavasoli@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-27, 1401/10/06
Expected recruitment end date
2023-01-26, 1401/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Outcomes of Tibial Shaft Fractures Treated by Dynamic Compression Plate and Intramedullary Nail
Public title
Comparison of two surgical methods Dynamic Compression Plate and Intramedullary Nail of tibial shaft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the age of 15 to 65 years Fracture formation following acute trauma The presence of a fracture in the diaphysis of the tibia
Exclusion criteria:
History of tibial bone fracture in two lower limbs Previous failure Open fracture History of underlying bone disease History of tibial bone fracture in two lower limbs Peroneal nerve damage Associated with proximal or distal fracture
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization is done using permutation blocks. Other blocks are considered 4. The ratio of two groups in each block is considered as 1:1. The Dynamic Compression Plate group is marked with A and the Intramedullary Nail group is marked with B. The creation of a random order in each block is done by a statistician.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2022-11-27, 1401/09/06
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.189

Health conditions studied

1

Description of health condition studied
Fracture of shaft of tibi
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia

Primary outcomes

1

Description
Knee pain after rod insertion
Timepoint
2 weeks, 4 weeks and 8 weeks and 12 weeks and two months after surgery
Method of measurement
Using the VAS scale & record severe pain intensity

Secondary outcomes

1

Description
Millionaire
Timepoint
12 weeks to 6 months after surgery
Method of measurement
Based on examination and radiography

2

Description
Not welding
Timepoint
6 months after surgery
Method of measurement
Based on examination and radiography

3

Description
Delay in welding
Timepoint
3-6 months after surgery
Method of measurement
Based on examination and radiography

4

Description
Infection after surgery
Timepoint
2 weeks, 4 weeks, 8 weeks, 12 weeks and two months after surgery
Method of measurement
Based on the findings of the examination, including warmth, swelling, erythema, pus discharge, and radiography

Intervention groups

1

Description
Intervention group: They are operated by Nile's intramedullary group method, where the rods are manufactured by Oswe company and are made of steel.
Category
Treatment - Surgery

2

Description
Control group: Using the Dynamic Compression Plate method, bone fixation is performed with AO Dynamic Compression Plate made by Asoeh Company, with at least 8 narrow holes.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Mehdi Tavasoli
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
m.tavasoli@mubabol.ac.ir
Web page address
https://mubabol.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
ramazan@yahoo.com
Web page address
https://mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Taziki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
mahdi.taziki@gmail.com
Web page address
https://mubabol.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Tavasoli
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Mehdi.tavasolii@gmail.com
Web page address
https://mubabol.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Tavasoli
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Mehdi.tavasolii@gmail.com
Web page address
https://mubabol.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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