Increase level of success in surgery of unstable femoral neck fracture in young patients.
Reduce of re-operation
Design
A clinical trial with no parallel group with no randomization. enrolled between 2018 and 2021.and followed for 6 months.
Settings and conduct
Mashhad kamyab hospital and Emam reza hospital.
After inabiltiy to Close reduction, open reduction was done with smith peterson approach and apply cannulated screw and then apply medial buttress plate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inability to close reduction in type 2 and 3 of the Pauwels classification of femoral neck fracture in patient between 18-60 years old.
Exclusion criteria: ability to close reduction, ipsilateral fracture, type 1
Intervention groups
Application of buttress medial plate in a patient with unstable femoral neck fracture(type 2,3) after open reduction and fixation with a cannulated screw.
Main outcome variables
The rate of the union in femoral neck fracture surgery
The need for re-operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049314N1
Registration date:2020-12-13, 1399/09/23
Registration timing:retrospective
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Ghasem Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3713 1292
Email address
ghasem.zamani92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-11-05, 1399/08/15
Actual recruitment start date
2019-08-23, 1398/06/01
Actual recruitment end date
2020-11-05, 1399/08/15
Trial completion date
2021-03-19, 1399/12/29
Scientific title
Evaluating the results of treatment in unstable femoral neck fractures with method of augmentation cannulated screw with medial buttress plate.
Public title
Evaluating the result of medial buttress plate in unstable femural neck fracture.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unstable femoral neck fractures in which close reduction is not applicable
Type 2, 3 in pauwels classification
Exclusion criteria:
Possibility of close reduction,
Type 1 in pauwels classification
Age
From 18 years old to 60 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Actual sample size reached:
8
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
No 342.Kolahdouz 17/1 Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9184944111
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.398
Health conditions studied
1
Description of health condition studied
Unstable femoral neck fracture
ICD-10 code
S72.00
ICD-10 code description
Fracture of unspecified part of neck of femur
Primary outcomes
1
Description
Union
Timepoint
2 weeks , 6weeks, 12 weeks, 6 months
Method of measurement
Pelvic x-ray, History and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: application of buttress medial plate in a patient with unstable femoral neck fracture(type 2,3) after open reduction and fixation with a cannulated screw.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamyab hospital, Mashhad
Full name of responsible person
Ghasem Zamani
Street address
Fadaeeyan Eslam.
City
Mashhad
Province
Razavi Khorasan
Postal code
١١١١١١١١١١
Phone
+98 51 3880 0280
Email
Ghasem.zamani92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Knowledge and Health City, Shahid Fakouri 94 Ave., Shahid Fakouri Blvd., Mashhad ,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
١١١١١١١١١١
Phone
+98 51 3880 0280
Email
Mds.research@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ghasem Zamani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 342. Kolahdouz 17/1 Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9184944111
Phone
+98 51 3713 1292
Email
Ghasem.zamani92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghasem Zamani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 342. Kolahdouz 17/1 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9184944111
Phone
+98 51 3713 1292
Email
Ghasem.zamani92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghasem Zamani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 342. Kolahdouz 17/1 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9184944112
Phone
+98 51 3713 1292
Email
Ghasem.zamani92@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
Pelvic x-ray
Physical examinations according to Harris hip score and Merle Questionnaires
When the data will become available and for how long
Access at the end of study
To whom data/document is available
Academic and industry Researchers
Under which criteria data/document could be used
Any researcher can access information by having a letter of introduction from the relevant organization, including industry and academia.
From where data/document is obtainable
Ghasem Zamani
Ghasem.zamani92@gmail.com
00989153062925
What processes are involved for a request to access data/document
Sending a request with a letter of introduction from the relevant organization to the phone number or email