Comparison of Fixation outcome of Intercondylar Fracture of Tibia Aminens between Sardar and Headless Screws
Design
The clinical trial with control group without blinding, phase 3 will be performed on 80 patients with iIntercondylar eminence fracture of the tibia. Patients will be randomly assigned to two parallel groups of 40 using the Excel Rand function. In one group, the iiIntercondylar eminence fracture of tibia will be fixed with headed screw. In the other group, a headless screw will be used to fix the iIntercondylar eminence fracture of the tibia.
Settings and conduct
This study will be performed on patients with iIntercondylar eminence fracture of tibia referred to Besat Hospital in Hamadan. no blinding will be done in this study
Participants/Inclusion and exclusion criteria
Participants in this study are patients with intercondylar fracture of the tibia. Patients with meniscus and ligament injuries with fractures will not be included in the study
Intervention groups
The first group intercondylar fracture will be fixed with headed screw. The second intervention group intercondylar fracture will be fixed with headless screw.
Main outcome variables
Fracture union, Leg function including: need or lack of support when standing and bearing weight, ability to climb stairs, ability to gradually bend the knee in a standing position, stability and instability of the knee, swelling and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N22
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of tibia intercondylar eminence fracture fixation between headed and headless screws
Public title
Methods for tibia intercondylar eminence fracture fixation between headed
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intracondylar fracture of the tibia
Exclusion criteria:
Comorbidity of meniscus and ligament damage
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly divided into two groups. 20 balls will be threw in a opaque bag, which includes 10 white balls and 10 black balls. With each patient, a ball is accidentally removed from the bag. If the color of the ball is white, Herbert screw will be used and if it is black, the cannula screw will be used. After each selection, the ball is returned to the bag
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 Hamadan Univercity of Medical Science
Street address
shahid fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.UMSHA.REC.1401.031
Health conditions studied
1
Description of health condition studied
tibia intercondylar eminence fracture
ICD-10 code
542.4
ICD-10 code description
Fracture of lower end of humerus
Primary outcomes
1
Description
Fracture union, leg function (no limping, no need for support while standing and bearing weight, ability to climb stairs, ability to gradually bend the knee in a standing position, stability and instability of the knee, swelling and pain)
Timepoint
Patients will be evaluated at three time intervals of weeks 4, 8 and 12 after treatment
Method of measurement
Union with radiography and leg function will be assessed with the lyshlom knee scale questionnaire. This questionnaire measures limping, the need for support while standing and bearing weight, the ability to climb stairs, the ability to gradually bend the knee in a standing position, knee stability and instability, swelling and pain.
2
Description
Fracture union
Timepoint
Patients will be evaluated at three time intervals of weeks 4, 8 and 12 after treatment
Method of measurement
Radiography of the fracture site
Secondary outcomes
1
Description
Infection and abscess at the surgical site
Timepoint
The first and second weeks after surgery
Method of measurement
Clinical examination of the patient and observation of the surgical site
Intervention groups
1
Description
Intervention group: Fracture fixation with Sardar Herbert screw
Category
Treatment - Devices
2
Description
Control group: Fracture fixation with headless screw cannula
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Gholamreza Ghorbani Amjad
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
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
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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan University of Medical Sciences, shahid fahmideh street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Amir Moayeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
Am7ir1993@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan University of Medical Sciences, shahid fahmideh street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
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