Evaluation and comparison of surgical results of pelvic fractures of APC type II and III by anterior pelvic plating method with anterior pelvic plating method and SI screw implantation in patients admitted to Ayatollah Kashani and Al-Zahra hospitals in Isfahan city
Evaluation and comparison of surgical results of pelvic fractures of APC type II and III by anterior pelvic plating method with anterior pelvic plating method and SI screw implantation
Design
This is a quasi-experimental study with two parallel groups, non-randomized, open-label.
Settings and conduct
This study is conducted in Ayatollah Kashani and Al-Zahra hospitals in Isfahan city. Patients with unstable pelvic fractures were included in the study based on the inclusion criteria and obtaining informed consent and will be treated non-randomly (based on clinical criteria and the specialist's decision) with one of the two usual methods. Finally, the process of response to treatment 2 weeks and 6 months after the operation will be compared by examining the amount of bone union.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirming informed consent, Age 18 to 80 years, unstable pelvic fracture. Exclusion criteria: Patients with the acetabulum, pubic ramus, and sacrum fracture.
Intervention groups
Intervention group 1: Patients who are candidates for elective surgery due to unstable pelvic fracture, in this group, undergo anterior pelvic plating surgery. Intervention group 2: Patients who are candidates for elective surgery due to unstable pelvic fracture, in this group, undergo anterior pelvic plating surgery and SI screw implantation.
Main outcome variables
Union
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N15
Registration date:2022-11-15, 1401/08/24
Registration timing:retrospective
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-03, 1400/08/12
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of surgical results of pelvic fractures of APC type II and III by anterior pelvic plating method with anterior pelvic plating method and SI screw implantation in patients admitted to Ayatollah Kashani and Al-Zahra hospitals in Isfahan city
Public title
Evaluation and comparison of anterior pelvic ring fixation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirming informed consent
Age 18 to 80 years
Unstable pelvic fracture
Exclusion criteria:
Patients with a fracture of the acetabulum, pubic ramus, and sacrum
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.MUI.MED.REC.1400.469
Health conditions studied
1
Description of health condition studied
Pelvic fracture
ICD-10 code
S32.811A
ICD-10 code description
Multiple fractures of pelvis with unstable disruption of pelvic ring, initial encounter for closed fracture
Primary outcomes
1
Description
Union
Timepoint
2 weeks and 6 months after surgery
Method of measurement
Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients who are candidates for elective surgery due to unstable pelvic fracture, in this group, undergo anterior pelvic plating surgery.
Category
Treatment - Surgery
2
Description
Intervention group: Patients who are candidates for elective surgery due to unstable pelvic fracture, in this group, undergo anterior pelvic plating surgery and SI screw implantation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Mohammad Mirmiran
Street address
Kashani St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
mohammadsharifi.ghasem@gmail.com
2
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Mohammad Mirmiran
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mohammad Mirmiran
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Fax
Email
hatmysyd314@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Mirmiran
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Fax
Email
hatmysyd314@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Mirmiran
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
hatmysyd314@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 data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Send a message to the mentioned e-mail address
What processes are involved for a request to access data/document
E-mail the responsible person and if you accept the conditions, the information will be