Comparison of one-year outcomes of Total Knee Arthroplasty with
Kinematic alignment and Mechanical Alignment regarding functionality and patient satisfaction in knee osteoarthritis patients
Design
Two-arm parallel-group, non-randomized, one-side blinded clinical trial on 72 patients
Settings and conduct
This one-sided, blinded orthopedic clinical trial will be conducted on osteoarthritis patients with two or 3-compartment involvement who have not responded to conservative treatment and are referred to Emam Hossein Hospital in 2022. Patients are classified into two groups, the control group was treated with the mechanical alignment technique, and the case group will be treated with the kinematic alignment technique. Functionality and patient satisfaction within one year of the operation will be assessed using WOMAC, OKS, physical examination, and imaging investigations.
Participants/Inclusion and exclusion criteria
Knee osteoarthritis patients with two or 3-compartment involvement who have not responded to conservative treatment are included in this study. Patients with a body mass index (BMI) above 40, a history of knee joint infection, osteoarthritis following trauma in the adjacent bones, bone osteotomy, underlying rheumatologic disease, and patients who did not cooperate or did not give their consent were excluded from the study.
Intervention groups
In this study, the intervention was conducted by using the kinematic alignment technique on 36 osteoarthritis patients with two or 3-compartment involvement who have not responded to conservative treatment
Main outcome variables
Use of better functioning knee arthroplasty techniques; Use of more patient-satisfying knee arthroplasty techniques
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221015056185N1
Registration date:2022-10-24, 1401/08/02
Registration timing:registered_while_recruiting
Last update:2022-10-24, 1401/08/02
Update count:0
Registration date
2022-10-24, 1401/08/02
Registrant information
Name
Mohammadmahdi Omidian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 3000
Email address
omid_medicine@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of one year outcomes of total knee arthroplasty with Kinematic alignment and mechanical alignment
Public title
Comparison of total knee arthroplasty outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoarthritis of the knee with 2 compartments involvement unresponsive to conservative therapy
Osteoarthritis of the knee with 3 compartments involvement unresponsive to conservative therapy
Exclusion criteria:
BMI above 40
History of infection in the knee
Osteoarthritis development after trauma to the bones around the knee
Osteotomy
Underlying rheumatological disease
The patient not having consent
The patient not being cooperative
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not informed of the study group they are assigned to; however, the surgeon and the research team know about the patients' assignment.
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
Intervention group: kinematic alignment (In this method, the purpose is reconstructing the knee joint in congenital and pre-disease alignment. In other words, the osteotomy is in a way in which the congenital alignment is rebuilt.)
Category
Treatment - Surgery
2
Description
Control group: mechanical alignment (In this method, the osteotomy is vertial to the mechanical axis of femur and tibia. Therefore a zero degree without varus or valgus is built.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Omidian
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Madani Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
omid_medicine@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Omidian
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Madani Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
omid_medicine@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Omidian
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Madani Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
omid_medicine@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In this study, data will be sharable after making it anonymous, upon request.
When the data will become available and for how long
Data can be shared, 3 months following publication upon request.
To whom data/document is available
University and research centers researchers can use the shared data.
Under which criteria data/document could be used
The data will be shared with researchers for research and academic purposes.
From where data/document is obtainable
Access to data will be through the correspondent author by email communication.
What processes are involved for a request to access data/document
Following submission for access to data, according to the correspondent judgment, the request will be assessed in a research team meeting, and if accepted, the data will be presented after becoming anonymous.