]>
IRCT20201027049159N1 IRCT 2020-10-30 Shahid Beheshti University of Medical Sciences Comparison of MA and KA Techniques in TKA 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 2017-03-21 anticipated 70 Complete https://irct.ir/trial/51875 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Knee osteoarthritis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All personal data of study participants can be shared after unidentification. When: Once the data is collected and analyzed, permanent access is possible. To whom: Access to data is available to all health researchers. Conditions: All data and documents can be published and used in the field of health research by mentioning the source. Where to obtain: For recieving all data and information, researchers could contact me on: 00989126083107 keyvanramezani@gmail.com How to obtain: Data will be provided to researchers within 1 month of their request. Comments:
public Keyvan Ramezani
Nezamabad
Tehran Iran (Islamic Republic of) 1646734861 +98 21 7343 0000 keyvanramezani@gmail.com Shahid Beheshti University of Medical Sciences scientific Keyvan Ramezani
Nezamabad
Tehran Iran (Islamic Republic of) 1646734861 +98 21 7343 0000 keyvanramezani@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Sever bilateral osteoarthritis Debilitating bilateral knee pain due to osteoarthritis Age>50 and age<80 50 years 80 years Both 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 M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery 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. 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. 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. Pain rate based on Visual Analogue Scale. Timepoint: Before surgery, 1, 3, 6, 12 month after surgery. Method of measurement: Visual Analogue Scale questionnaire. Knee Range of Motion. Timepoint: Before surgery, 1, 3, 6, 12 month after surgery. Method of measurement: Goniometer. 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. Duration of surgery. Timepoint: After surgery. Method of measurement: Duration of tourniquet time in minutes. 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. Shahid Beheshti Medical University Approved 2020-10-27 Ethics committee of Shahid Beheshti University of Medical Sciences No 1, Koodakyar alley, Daneshju Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)