Investigation and comparison of the treatment of non-union fractures of the femur by two methods of nail exchange and the use of bone grafting along with plate augmentation.
Determining and comparing the treatment of non-union fractures of the femur by two methods of nail exchange and the use of plate augmentation
Design
This study will be conducted in the form of a clinical trial with a control group with two randomized parallel groups and without blinding on 40 patients among the population of patients with non-union femur fractures. Patients will be randomly assigned to one of the study groups. A table of random numbers will be used for randomization.
Settings and conduct
This study will be conducted in the city of Isfahan in 2023 as a clinical trial in the population of patients with non-union femur fracture. After randomization, patients will be divided into one of two study groups. Blinding was not done. The first group will be treated with intermedullary nailing and the second group will be treated with plate augmentation.
Participants/Inclusion and exclusion criteria
1. Patients with transverse and oblique fractures (the fracture line with the axis of the femoral medulla has an angle of less than 45 degrees) femur treated with intra-medullary nail; 2. Diagnosis of non-union by an orthopedic specialist 6 months after surgery; 3. Candidate for surgery to correct non-union; 4. Informed consent.
Intervention groups
All patients will be placed in two groups. The first group will be treated with intermedullary nailing and the second group will be treated with plate augmentation
Main outcome variables
Bony union
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230211057388N1
Registration date:2023-03-05, 1401/12/14
Registration timing:registered_while_recruiting
Last update:2023-03-05, 1401/12/14
Update count:0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
Mohammad Shahsavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8672 5503
Email address
mohammad1443shah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the treatment of non-union fractures of the femur by two methods of nail exchange and the use of bone grafting along with plate augmentation.
Public title
Non-union femoral shaft fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with transverse and oblique fractures (the fracture line with the axis of the femoral medulla has an angle of less than 45 degrees) femur treated with intra-medullary nail
Diagnosis of non-union by orthopedic specialist 6 months after surgery
A candidate for surgery to correct non-union
Informed consent
randomization will be done with the help of random number table. If the number is even, it will belong to the first group, and if it is odd, it will belong to the second group.
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 isfahan university of medical science
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-08, 1400/08/17
Ethics committee reference number
IR.MUI.MED.REC.1400.624
Health conditions studied
1
Description of health condition studied
Femoral fracture non union
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
Bony union
Timepoint
3 and 6 months postoperatively
Method of measurement
Medical history, physical exam, radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intramedullary nailing. The intramedullary canal will be over-reamed several sizes, and a nail at least 1 mm (ranging from 1 to 3 mm) larger in diameter will be inserted. The average initial nail diameter.
Category
Treatment - Devices
2
Description
Intervention group: plate augmentation. An augmentation plate with autogenous bone grafting will be performed after exposing the nonunion site using the lateral approach. Cortico-cancellous bone grafts from ipsilateral iliac crest will be harvested simultaneously by another surgical team. We will use dynamic compression plates (DCP) with eight holes
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mohammad Shahsavan
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohammad_shah69@res.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooy
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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 Shahsavan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohammad_shah69@res.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad shahsavan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohammad_shah69@res.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Shahsavan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohammad_shah69@res.mui.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