Comparison of Outcomes of Kinematic Alignment and Mechanical Alignment Techniques in Patients with Bilateral Severe Osteoarthritis Who Underwent Single Surgeon Simultaneous Bilateral Primary Total Knee Arthroplasty
This study aimed to compare the results of two techniques in TKA in terms of postoperative complications, duration of surgery, postoperative functional outcome, postoperative radiologic outcome.
Design
Two arm parallel group randomised trial with double blinded postoperative care and outcome assessment, each group contains 39 patients.
Settings and conduct
Cases are selected among the patients of the knee orthopedic clinic of Imam Hossein, medical training center in tehran who are candidates for TKA surgery with a diagnosis of severe bilateral osteoarthritis of the knee.
Knee alignment is measured before joint replacement surgery with a 3joint view x-ray. Also, the Oxford Knee Score and Visual Analog Scale Score forms will be completed before and after surgery under the supervision of a physician. Surgery time, infection rate, and range of motion will also be measured after surgery (on each knee)
Participants/Inclusion and exclusion criteria
Including criteria:
Sever bilateral osteoarthritis
Debilitating bilateral knee pain due to osteoarthritis
Age<50
Excluding criteria:
Sever underlying diseases which make anesthesia impossible
Recurrent UTI
BMI<20 or BMI>50
History of osteomielitis around knee
Neuropathic arthropathy
Active or recent infection other than knee
Pain free nonfunctional osteoarthritis
Genu Recurvatum due to muscular disorders
Disruption in knee extensor mechanism
Active or recent knee infection
Age>80
Intervention groups
Each knee in a patient will underwent different technique (MA or KA)
Main outcome variables
Body Mass Index, length of surgery, infection rate, joint range of motion, Western Ontario and McMaster Universities Osteoarthritis Index, Visualized analogue scale Score, Oxford Knee Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049159N1
Registration date:2020-10-30, 1399/08/09
Registration timing:retrospective
Last update:2020-10-30, 1399/08/09
Update count:0
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Keyvan Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
keyvanramezani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2020-09-22, 1399/07/01
Scientific title
Comparison of Outcomes of Kinematic Alignment and Mechanical Alignment Techniques in Patients with Bilateral Severe Osteoarthritis Who Underwent Single Surgeon Simultaneous Bilateral Primary Total Knee Arthroplasty
Public title
Comparison of MA and KA Techniques in TKA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sever bilateral osteoarthritis
Debilitating bilateral knee pain due to osteoarthritis
Age>50 and age<80
Exclusion criteria:
Sever underlying diseases which make anesthesia impossible
Recurrent UTI
BMI<20 or BMI>50
History of osteomielitis around knee
Neuropathic arthropathy
Active or recent infection other than knee
Pain free nonfunctional osteoarthritis
Genu Recurvatum due to muscular disorders
Disruption in knee extensor mechanism
Active or recent knee infection
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
2
Right knee and left knee
Actual sample size reached:
78
More than 1 sample in each individual
Actual sample size in each individual:
2
Right knee and left knee
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random number table, patients devided in to two groups, in first one, right knee will be replaced by kinematic technique and left knee will be replaced by mechanical technique and in the second group right knee will be replaced by mechanical technique and left knee will be replaced by kinematic technique.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and their caregivers do not know which technique is used for each knee.
Beside the main surgeon, neither medical team members nor research team members do no know which technique is used for each knee.
Statistics consultant does not know which technique is used for each knee.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No 1, Koodakyar alley, Daneshju Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.SBMU.MSP.REC.1399.381
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee functional score on the Oxford Knee Questionnaire
Timepoint
Before surgery, 1, 3, 6, 12 month after surgery
Method of measurement
Oxford Knee Score Questionnaire
2
Description
Pain rate based on Visual Analogue Scale
Timepoint
Before surgery, 1, 3, 6, 12 month after surgery
Method of measurement
Visual Analogue Scale questionnaire
3
Description
Knee Range of Motion
Timepoint
Before surgery, 1, 3, 6, 12 month after surgery
Method of measurement
Goniometer
4
Description
Rate of knee joint infection after surgery
Timepoint
1, 3, 6, 12 month after surgery
Method of measurement
Clinical evaluation and CRP (C-reactive protein) and ESR ((Erythrocyte Sedimentation Rate) level
5
Description
Duration of surgery
Timepoint
After surgery
Method of measurement
Duration of tourniquet time in minutes
6
Description
Score based on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Timepoint
Before surgery, 1, 3, 6, 12 month after surgery
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is the group in which the right knee is replaced by Kinematic alignment method and the left knee is replaced by Mechanical alignment method. In general, the classic method of knee replacement is called mechanical alignment method, which has been used since the 20th century, but since the early third millennium, Kinematic Alignment methid was also introduced. In this study, we compare the results of these two methods. In both methods, Zimmer's primary total knee arthroplasty prosthesis are used. The basis of the mechanical method is to create an alignment along the overall mechanical axis of the limb. The surface of the knee joint in this method is perpendicular to the mechanical axis of the limb, but in fact even in people without osteoarthritis of the knee and without symptoms of pain and limited movement of the knee, the surface of the knee joint is not perpendicular to the mechanical axis of the limb, but the knee inherently It is slightly in the varus, so in the kinematic method our goal is to establish the overall alignment of the limb and the knee joint based on the patient's native position before osteoarthritis (not necessarily to adjust the joint surface perpendicular to the mechanical axis of the limb) and this is concept of the kinematic method.
Category
Treatment - Surgery
2
Description
Intervention group: The second group is the group in which the right knee is replaced by Mechanical alignment method and the left knee is replaced by Kinematic alignment method. In general, the classic method of knee replacement is called mechanical alignment method, which has been used since the 20th century, but since the early third millennium, Kinematic Alignment methid was also introduced. In this study, we compare the results of these two methods. In both methods, Zimmer's primary total knee arthroplasty prosthesis are used. The basis of the mechanical method is to create an alignment along the overall mechanical axis of the limb. The surface of the knee joint in this method is perpendicular to the mechanical axis of the limb, but in fact even in people without osteoarthritis of the knee and without symptoms of pain and limited movement of the knee, the surface of the knee joint is not perpendicular to the mechanical axis of the limb, but the knee inherently It is slightly in the varus, so in the kinematic method our goal is to establish the overall alignment of the limb and the knee joint based on the patient's native position before osteoarthritis (not necessarily to adjust the joint surface perpendicular to the mechanical axis of the limb) and this is concept of the kinematic method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Mohammad Mahdi Sarzaeem
Street address
Nezamabad
City
Thran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
keyvanramezani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 1, koodakyar alley, Daneshju Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti Medical University
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Keyvan Ramezani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Nezamabad
City
Tehran
Province
Tehran
Postal code
1646734861
Phone
+98 21 7343 0000
Fax
Email
keyvanramezani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Keyvan Ramezani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Nezamabad
City
Tehran
Province
Tehran
Postal code
1646734861
Phone
+98 21 7343 0000
Fax
Email
keyvanramezani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Keyvan Ramezani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Nezamabad
City
Tehran
Province
Tehran
Postal code
1646734861
Phone
+98 21 7343 0000
Fax
Email
keyvanramezani@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
All personal data of study participants can be shared after unidentification.
When the data will become available and for how long
Once the data is collected and analyzed, permanent access is possible.
To whom data/document is available
Access to data is available to all health researchers.
Under which criteria data/document could be used
All data and documents can be published and used in the field of health research by mentioning the source.
From where data/document is obtainable
For recieving all data and information, researchers could contact me on:
00989126083107
keyvanramezani@gmail.com
What processes are involved for a request to access data/document
Data will be provided to researchers within 1 month of their request.