Prevalence and causes of persistent pain in patients after total knee arthroplasty in one year follow-up
Design
Clinical trial without control group, phase 3 on 300 patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Patients will undergo surgery, then patients' pain before and one month, three months and one year after the intervention will be measured by the Western Ontario and McMaster Osteoarthritis Index.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for knee replacement surgery (TKA), knee pain due to severe osteoarthritis with and without severe deformity, severe pain due to chondrocalcinosis and pseudogout, severe patellofemoral arthritis in the elderly, consent to participate in this study. Exclusion criteria: active or recent infection of the knee, active infection in another specific part of the body, extensor mechanism mechanism, recurvatum due to muscular problem, functional and painless arthrodesis
Intervention groups
Intervention group: Patients in this group undergo total knee arthroplasty surgery. Patients' pain before and one month, three months and one year after the intervention is measured by the Western Ontario and McMaster Osteoarthritis Index.
Main outcome variables
Intensity of pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N7
Registration date:2020-12-22, 1399/10/02
Registration timing:prospective
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
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
2020-12-24, 1399/10/04
Expected recruitment end date
2021-01-25, 1399/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevalence and causes of persistent pain in patients after total knee arthroplasty in one year follow-up
Public title
Prevalence and causes of persistent pain in patients after total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Candidate for Knee Replacement Surgery (TKA)
Knee pain due to severe osteoarthritis with and without severe deformity
Severe pain due to chondrocalcinosis and pseudogout
Severe patellofemoral arthritis in the elderly
Having informed consent of patients to participate in the study
Exclusion criteria:
Active or recent knee infection
Active infection in another specific part of the body
Extensor mechanism disorder
Recurvatum due to muscular problem
Functional and painless arthrodesis
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
300
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MUI.MED.REC.1399.755
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M16
ICD-10 code description
Osteoarthritis of hip
Primary outcomes
1
Description
Pain
Timepoint
Before and one month and three months and one year after the intervention
Method of measurement
Western Ontario and McMaster Osteoarthritis Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group undergo total knee arthroplasty surgery. Patients' pain before and one month, three months and one year after the intervention is measured by the Western Ontario and McMaster Osteoarthritis Index.
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.