Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and concellous screws in osteoporotic patients
Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and cancellous screws in osteoporotic patients
Design
In this clinical efficacy study, after the approval and obtaining the code of ethics and the IRCT code, 40 patients from all patients referred to Shahada Training Center in Tabriz who have a fracture inside the femoral neck capsule and are indicated for internal fixation with screws will be included in the study. Patients will be divided into two groups based on simple randomization method
Settings and conduct
40 people from all patients referred to Tabriz Martyrs Education Center
Participants/Inclusion and exclusion criteria
Eligible patients met all of the following inclusion criteria: (1) male or female with no upper age limit; (2) femoral neck fracture confirmed by radiography of the hip and femur, computed tomography, or magnetic resonance imaging (MRI).
We will exclude patients who do not meet any of the following criteria: patients not suitable for intracapsular fixation (ie, severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
Intervention groups
First group: internal fixation with three 6.5 mm cannulated screws with inverted triangle method. The second group: internal fixation with three 6.5 mm cancellous screws with the inverted triangle method.
Main outcome variables
Stabilization in femoral neck fractures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221113056482N1
Registration date:2023-02-21, 1401/12/02
Registration timing:retrospective
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Alireza Sadeghpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 550 2800
Email address
alirezasadeghpuor17@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and concellous screws in osteoporotic patients
Public title
Comparison of internal fixation results of intracapsular fracture of the femoral neck by two methods of cannula screws and concellous screws in osteoporotic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men or women with no upper age limit
Femoral neck fracture confirmed by radiography of the hip and femur, computed tomography, or magnetic resonance imaging (MRI)
Operative treatment of fractures within 4 days of visiting the emergency room, or operation of non-displaced fractures within 7 days of visiting the emergency room.
The patient was ambulatory before the fracture, although she may have used an aid such as a cane or walker
Predictive medical optimization for hip surgery
Provision of informed consent by the patient or designated legal representative
Do not have any other major trauma such as another fracture, according to the supervisor's judgment
Exclusion criteria:
Patients not suitable for intracapsular fixation (ie, severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
Age
From 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the "Random Allocation Law" method was used so that the numbers for randomization were written on cards in order. Even numbers were considered for the first group (internal fixation with three cannulated screws of 6.5 mm with the inverted triangle method) and odd numbers for the second group (internal fixation with three cancellous screws of 6.5 mm with the inverted triangle method). In this method, the number of people assigned to each group will be balanced at the end of the study.
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 Tabriz University of Medical Sciences
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.497
Health conditions studied
1
Description of health condition studied
Femoral neck fracture in osteoprotic patients
ICD-10 code
S72.0
ICD-10 code description
Fracture of head and neck of femur
Primary outcomes
1
Description
Fixation of intracapsular fracture of femoral neck
Timepoint
The patient is followed up in the clinic for two weeks, one month, three months, six months and annually for up to 3 years to record clinical and radiological results.
Method of measurement
After the operation, the clinical results will be evaluated in the form of scoring in each visit. Welding will be checked with graphs in face view with 15 degrees of internal rotation of the legs and profile view. The creation of trabeculae from between the fracture line will be considered as welding. Non-union is considered as no formation of said trabeculae, redistribution or progressive. Full weighting will be allowed by ensuring welding in the graph. If re-surgery is required, follow-up will be done before re-surgery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: internal fixation with three 6.5 mm cannulated screws with inverted triangle method (standard treatment). After being fixed in the supine position in a special orthopedic bed, they receive spinal anesthesia or general anesthesia and undergo closed reduction under c-arm control. Then, with the standard lateral approach, the placement of the screws is determined with Kirschner rods.
Category
Treatment - Surgery
2
Description
Intervention group: Internal fixation with three 6.5 mm cancellous screws using the inverted triangle method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical Research & Training Hospital
Full name of responsible person
Alireza Sadeghpour
Street address
Shohada Medical Research & Training Hospital, Golshahr street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3765
Email
alirezasadeghpuor17@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Third floor, Central building No. 2, Tabriz University of medical Sciences, Golgasht Blvd., Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4664
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Sadeghpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shohada Medical Research & Training Hospital, Golshahr street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3765
Email
amir.valizadeh67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Sadeghpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shohada Medical Research & Training Hospital, Golshahr street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3765
Email
alirezasadeghpuor17@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Sadeghpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shohada Medical Research & Training Hospital, Golshahr street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3765
Email
alirezasadeghpuor17@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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After making people unidentifiable, the results will be published in the form of dissertations and articles
When the data will become available and for how long
Access starts After preparing the results
To whom data/document is available
All of the researchers
Under which criteria data/document could be used
Examining and expanding the results
From where data/document is obtainable
Shahab Mahdipour Email: shahab5mph@gmail.com
What processes are involved for a request to access data/document
Contact by email up to one month after the request