Comparison of outcomes and prognosis of treatment in femoral neck fracture patients with bipolar hemiarthroplasty and plate fixation (Dynamic Hip Screw ) (DHS )
Design
A randomized controlled clinical trial with randomized groups with random number table (30 random numbers in each groups) to evaluate and compare surgical outcome and results.
Settings and conduct
Patients 60 years and older referred to Taleghani Hospital in Kermanshah city with femoral neck fractures up to first 72 hours after their fracture enrolled in study.By using random table number assigned to two groups, plate fixation and hemi-arthroplasty and operation performed and then patients were evaluated 3 and 6 months after surgery by the Haris Hip Score and Visual Analogue Score as well as complications (infection, union, and fracture) are compared between the two groups
Participants/Inclusion and exclusion criteria
Patients undergoing surgical operation due to basicervical femoral neck fracture up to 72 hours after fracture; age 60 or older; No significant cognitive impairment; No chronic disease such as respiratory disease; Ability to walk before fracture without aids
Intervention groups
Utilizing two methods : Intervention group with bipolar hemiarthrplasty method and control group with plate fixation with (Dynamic Hip Screw ) (DHS ) were operated.
Main outcome variables
Age; Sex; Comorbidities such as osteoarthritis and rheumatoid arthritis, diabetes; Quality of life and activity level based on Haris Hip Score and Visual Analogue Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180904040953N1
Registration date:2020-02-16, 1398/11/27
Registration timing:prospective
Last update:2020-02-16, 1398/11/27
Update count:0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Adel Hojabrian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 7989
Email address
adel.hojabrian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-04, 1398/12/14
Expected recruitment end date
2020-08-18, 1399/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bipolar hemiarthroplasty with reduction and fixation with Dynamic hip screw(DHS) in basicervical femoral neck fractures' patients
Public title
Evaluation of bipolar hemiarthroplasty and plating in femoral neck fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Basicervical femoral neck fracture
Exclusion criteria:
Re-operation of femoral neck fracture
Other limb fractures
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by a random number table, the researcher first determines the direction of numbers to read (e.g up, down, left or right) as well as considers for the control group,even numbers and the intervention group, odd numbers .Then, the researcher puts his hand on one of the numbers in the predetermined direction and records the numbers and assigns them to the considered 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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd. Kermamshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-01-17, 1398/10/27
Ethics committee reference number
IR.KUMS.REC.1398.956
Health conditions studied
1
Description of health condition studied
Basicervical femoral neck fracture
ICD-10 code
S72.04
ICD-10 code description
Fracture of base of neck of femur
Primary outcomes
1
Description
Assessment of quality of life
Timepoint
Three and six months after surgery
Method of measurement
Haris Hip Score
2
Description
Assessment of pain
Timepoint
Three and six months after surgery
Method of measurement
Visual Analogue scale
Secondary outcomes
1
Description
Union
Timepoint
Three and six months after surgery
Method of measurement
Radiography
2
Description
Infection
Timepoint
Six weeks;three months and 6 months after surgery
Method of measurement
Clinical judgment; Positive culture;C-reactive protein
Intervention groups
1
Description
Intervention group: Patients with basicervical femoral neck fracture undergo surgery by bipolar hemiarthroplasty method and compared with the control group 3 and 6 months after surgery for union, infection, and hip assessment score as well as pain score.
Category
Treatment - Surgery
2
Description
Control group: Patients with basicervical femoral neck fracture undergo surgery by plate fixation(DHS) method and compared with the intervension group 3 and 6 months after surgery for union, infection, and hip assessment score as well as pain score.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Ali Mousapour
Street address
Shahid Beheshti Blvd. Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 7752
Fax
Email
ali.mousapour@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd. Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 7752
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Adel Hojabrian
Position
Orthopedic Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd.Taleqani Hospital. kermanshah city
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Fax
Email
adel.Hojabrian@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Adel Hojabrian
Position
Orthopedic Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd.Taleqani Hospital. kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Fax
Email
adel.Hojabrian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Adel Hojabrian
Position
Orthopedic Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd.Taleqani Hospital. Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Fax
Email
adel.Hojabrian@kums.ac.ir
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
Collected data is shareable after people were deidentified.
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
The data is available only for people who work in academic institutions.
Under which criteria data/document could be used
Any analysis isn't allowed on the document.
From where data/document is obtainable
The preferred way for communication is via email address: Adel.Hojabrian@kums.ac.ir. The postal address is Kermanshah Town; Shahid Beheshti Blvd; Taleqani hospital. The telephone number is +98 83 38357752 and the contact person is Adel.Hojabrian.
What processes are involved for a request to access data/document
The requests will be assessed and the data would be available in one month.