Comparison of the results and complications of suprapatellar and infrapatellar methods in tibial nailing in patients with leg fracture
Design
Patients with conditions after entering the study are divided into two groups of suprapatellar intervention and infrapatellar control by Random number software. The groups of this study are parallel. According to statistical analysis, the sample size of this study is 112 patients. After grouping, patients undergo surgery and follow-up care.
Settings and conduct
This study is conducted at Hamadan University of Medical Sciences and Besat hospital, and after selecting the patients and grouping them, each group is subjected to the respective surgery after the surgery, multiple follow-ups are done for the patients on a weekly and monthly basis, and the relevant questionnaires are completed All people related to the treatment of the patients except the surgical team and the patients themselves are blinded in this study
Participants/Inclusion and exclusion criteria
Entry conditions include tibial trunk fracture
The conditions of non-entry include any problems in the IMN treatment in such a way that this method cannot be used, as well as the patients' lack of satisfaction
Intervention groups
Intervention group 1: Supra patellar treatment. Intervention group 2: Infrapatellar treatment.
Main outcome variables
Knee functional score; Knee pain score; Welding rate; Irritability; Duration of operation; The number of complications; Knee range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220821055759N1
Registration date:2022-09-07, 1401/06/16
Registration timing:prospective
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Milad Alizadehhaghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 921 189 4019
Email address
miladalizadeh57@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment results in suprapatellar and infrapatellar intramedullary nailing for tibial shaft fractures
Public title
Treatment results in suprapatellar and infrapatellar intramedullary nailing for tibial shaft fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
shaft fracture of tibia
Exclusion criteria:
Failure to accept the patient or inability to use the IMN method for any other reason
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The list of people with inclusion criteria is selected by random numbers using the Random number application in two separate lists with an equal number of men and women who undergo surgery.
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 Hamedan University of Medical Sciences
Street address
Shahid Fahmide boulevard
City
Hamedan
Province
Hamadan
Postal code
7451814948
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.UMSHA.REC.1401.464
Health conditions studied
1
Description of health condition studied
Tibial shaft fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of Tibia without Fibula
Primary outcomes
1
Description
Knee score in Lysholm knee score
Timepoint
6weeks, 3monthes, 6months, 1 year
Method of measurement
Lysholm knee score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with supra ptellar nailing
Category
Treatment - Surgery
2
Description
Control group: Treatment with infra ptellar nailing
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Besat hospital
Full name of responsible person
Dr Sepehr Shiroee
Street address
Besat boulevard
City
Hamedan
Province
Hamadan
Postal code
7426359875
Phone
+98 81 3264 0020
Email
www.malizadehhaghighi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Vahid Shamsaee
Street address
Shahid Fahmideh street
City
Hamedan
Province
Hamadan
Postal code
7456236173
Phone
+98 81 3131 0020
Email
malizadehhaghighi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
80
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sepehr Shirouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Besat boulevard
City
Hamedan
Province
Hamadan
Postal code
7456328759
Phone
+98 918 388 7587
Email
sepehr.shirouei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Gholam Reza Qorbaniamjad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Eram boulevard
City
Hamedan
Province
Hamadan
Postal code
7563529821
Phone
+98 918 324 5765
Email
gholamrezaghorbaniamjad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Gholam Reza Qorbaniamjad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Eram boulevard
City
Hamedan
Province
Hamadan
Postal code
7543628798
Phone
+98 918 331 4657
Email
gholamrezaqorbaniamjad@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
All the data after the individuals cannot be identified are recorded in the archive of the clinical studies center of Hamadan Ba'ath Hospital and can be presented to the relevant people to conduct other studies.
When the data will become available and for how long
It is possible to start accessing the data of this study 6 months after publication.
To whom data/document is available
Access is free for everyone
Under which criteria data/document could be used
There are no special conditions for using the data of this study
From where data/document is obtainable
Those interested can use this information by referring to the website of the journal in which the article was published
What processes are involved for a request to access data/document
as soon as possible by referring to the journal website or comprehensive sites