Comparison of the result of intramedullary nailing by static and dynamic static methods in the corrosion weld of shaft fractures of femur and tibia bones.
Design
In the first group, nailing will be done by a static method and in the second group by a dynamic method. The sample size is 102 people, which will be assigned to one of these two groups using the block randomization method. The design of the study will be concurrent. The usual phases of the clinical trial are not applicable in this study. Also, the study will be conducted in a un blind manner.
Settings and conduct
This study will be conducted in Shahid Madani Hospital of Karaj. after obtaining informed consent from the eligible people, the people will be randomly divided into two groups of static and dynamic nailing. For this purpose, quadruple blocks (A, A, B, B) will be created and two groups of people will be formed in each block. These blocks will be created randomly so that in each group, the number of people in the study phase is almost equal. Therefore, at each stage of the study, a block was randomly selected and then people were assigned to the relevant group according to the order in which they appeared in that block. (A static nailing group, B dynamic nailing group).
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-18 to 80 years old.2-Informed consent.3-Having a fracture of the transverse or short inclination type.4-The time to go to the hospital is less than two weeks after the fracture
Exclusion criteria:1-Open fractures.2-Fractures with chopped parts.3-Fractures associated with neurovascular injuries.4-Fractures previously treated with intramedullary nailing or periprosthetic fractures.5-Diabetes.6-Osteoporosis
The end result of bone healing
Duration of complete bone healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220201053910N1
Registration date:2022-07-04, 1401/04/13
Registration timing:registered_while_recruiting
Last update:2022-07-04, 1401/04/13
Update count:0
Registration date
2022-07-04, 1401/04/13
Registrant information
Name
Ali Sedighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3440 3843
Email address
sedighiali112@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of intramedullary nailing by static and dynamic methods in the erosion of femur and tibia shaft fractures.
Public title
Comparison of the result of intramedullary nailing by static and dynamic methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 80 years old
Informed consent
Having a fracture of the transverse or short inclination type
The time to go to the hospital is less than two weeks after the fracture
Exclusion criteria:
Open fractures
Fractures with chopped parts
Fractures associated with neurovascular injuries
Fractures previously treated with IMN or periprosthetic fractures
Diabetes
Osteoporosis
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after obtaining the informed consent of eligible individuals, individuals will be randomly divided into two groups: static and dynamic IMN. For this purpose, quadruple blocks (A, A, B, B) will be created and two groups of people will be formed in each block. These blocks are created randomly so that in each group, the number of people in the study stage is almost equal. Therefore, at each stage of the study, a block (allocation of four symbols inside the block is random and there are many blocks) is randomly selected and then people will assign to the relevant group in the order in which the block appears. (A group will be static IMN, B group will be dynamic IMN).
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 Alborz University of Medical Sciences
Street address
mahan blvd-shahid madani hospital-Clinical Research Development Unit
City
karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.abzums.rec.1400.234
Health conditions studied
1
Description of health condition studied
Fractures of the femoral shaft and tibia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The final result of welding based on clinical and radiological evaluation (Harper criteria)
Timepoint
Examinations will be done immediately after the surgery and then 8 weeks later and after that at intervals of 4 weeks to 6 months and the last visit and imaging will be done 9 to 21 months after the surgery.
Method of measurement
Patients in both groups will be regularly examined and visited and photographed in two views and profile of the fracture site.
2
Description
Duration of complete welding
Timepoint
Examinations will be done immediately after the surgery and then 8 weeks later and after that at intervals of 4 weeks to 6 months and the last visit and imaging will be done 9 to 21 months after the surgery.
Method of measurement
Patients in both groups will be regularly examined and visited and photographed in two views and profile of the fracture site.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the static intramedullary nailing method will be used to fix the fracture in such a way that 3 to 4 screws are used at both ends to prevent vertical and rotational instability and bending.
Category
Treatment - Devices
2
Description
Control group: In this group, the dynamic intramedullary nailing method will be used. In this way, a distal or proximal screw will be used that allows vertical pressure to control rotational instability and bending.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital, Karaj
Full name of responsible person
Ali Sedeghi
Street address
Mahan blvd-shahid madani hospital-Clinical Research Development Unit
City
Karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Phone
+98 26 3420 9028
Email
sedighiali112@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Sedeghi
Street address
Mahan blvd-shahid madani hospital.Clinical Research Development Unit
City
Karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Phone
+98 26 3420 9028
Email
sedighiali112@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Ali Sedighi
Position
Orthopedic Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mahan blvd-Shahid madani hospital-Clinical Research Development Unit
City
Karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Phone
+98 26 3420 9028
Email
sedighiali112@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Sedigi
Position
Orthopedic Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mahan blvd-Shahid madani hospital-Clinical Research Development Unit
City
karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Phone
+98 26 3420 9028
Email
sedighiali112@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Sedighi
Position
Orthopedic Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mahan blvd-Shahid madani hospital-Clinical Research Development Unit
City
Karaj
Province
Alborz
Postal code
۳۱۴۳۷۴۴۶۹۳
Phone
+98 26 3420 9028
Email
sedighiali@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
1. Participants' data file will be shared after de-identifying individuals
2- The study protocol will be shared after the study
3- The statistical analysis map will be shared after the study
4- The informed consent form will be shared after the study
5- The statistical analysis map will be shared after the study
6. The clinical study report will be shared after the study
7. The codes used in the analysis will be shared after the study
8. The data classification system will be shared after the study
When the data will become available and for how long
The data access period will start 6 months after the publication of the study results
To whom data/document is available
All people working in the field of medical sciences will be allowed to access the data
Under which criteria data/document could be used
Medical researchers can use the results of this study to conduct medical research, provided that they follow the principles of such research, such as non-copying.
From where data/document is obtainable
Applicants can refer to the Clinical Research Development Unit of Madani Karaj Hospital at the address of Karaj, Mahan Blvd., Madani Hospital, Clinical Research Development Unit, to receive data.
They can also email sedighiali112@gmail.com
What processes are involved for a request to access data/document
Applicants' request for data use will be reviewed by the Clinical Research Development Unit of the Civil Hospital and if this unit agrees, the data will be provided to the applicants.