Evaluation and comparison of total hip arthroplasty results by cup placement in true or false acetabulum in patients with hip dysplasia with crow classification groups 3 and 4
Evaluation and comparison of total hip arthroplasty results by cup placement in true or false acetabulum in patients with hip dysplasia with crow classification groups 3 and 4
Design
Clinical trial without control group, phase 3 on 64 patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Selected patients undergo hip arthroplasty surgery to place the prosthesis in the true and false acetabulum. After the operation, the amount of pain and range of motion of the patients are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: developmental congenital hip dysplasia of crow 3 and 4; complete hip replacement for patients unilaterally or bilaterally; obtaining written consent. Exclusion criteria: defective information in the file; lack of access to the patient to complete the information; other skeletal abnormalities.
Intervention groups
Intervention group 1: patients in this group undergo hip arthroplasty by placing a prosthesis in the false acetabular cavity. One month and three months after surgery, patients' pain and range of motion of the hip joint will be measured and compared. Intervention group 2: patients in this group undergo hip arthroplasty by placing a prosthesis in the true acetabular cavity. One month and three months after surgery, patients' pain and range of motion of the hip joint will be measured and compared.
Main outcome variables
Pain and range of motion of the joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N5
Registration date:2020-10-20, 1399/07/29
Registration timing:prospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2020-11-14, 1399/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of total hip arthroplasty results by cup placement in true or false acetabulum in patients with hip dysplasia with crow classification groups 3 and 4
Public title
Total hip arthroplasty by inserting a cup into a true or false acetabulum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Developmental congenital hip dysplasia of crow 3 and 4
Complete hip replacement for patients unilaterally or bilaterally
Obtaining written consent
Exclusion criteria:
Defects in the information required by the file
Lack of access to the patient to complete the information
Another skeletal abnormality
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
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
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.MUI.MED.REC.1397.072
Health conditions studied
1
Description of health condition studied
Developmental congenital hip dysplasia
ICD-10 code
Q87.5
ICD-10 code description
Other congenital malformation syndromes with other skeletal changes
Primary outcomes
1
Description
Pain
Timepoint
1 month and 3 months after intervention
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Joint range of motion
Timepoint
1 month and 3 months after intervention
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: patients in this group undergo hip arthroplasty by placing a prosthesis in the false acetabular cavity. One month and three months after surgery, patients' pain and range of motion of the hip joint will be measured and compared.
Category
Treatment - Surgery
2
Description
Intervention group 2: patients in this group undergo hip arthroplasty by placing a prosthesis in the true acetabular cavity. One month and three months after surgery, patients' pain and range of motion of the hip joint will be measured and compared.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Motififard
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
motififard@med.mui.ac.ir
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
Web page address
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
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.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
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
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.