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IRCT20221015056185N1 IRCT 2022-10-24 Shahid Beheshti University of Medical Sciences Comparison of total knee arthroplasty outcomes Comparison of one year outcomes of total knee arthroplasty with Kinematic alignment and mechanical alignment 2022-08-23 anticipated 72 Complete https://irct.ir/trial/66366 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Osteoarthritis of knee. Intervention 1: 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.). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: In this study, data will be sharable after making it anonymous, upon request. When: Data can be shared, 3 months following publication upon request. To whom: University and research centers researchers can use the shared data. Conditions: The data will be shared with researchers for research and academic purposes. Where to obtain: Access to data will be through the correspondent author by email communication. How to obtain: 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. Comments:
public Mohammad Mahdi Omidian
Madani Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 omid_medicine@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mohammad Mahdi Omidian
Madani Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 omid_medicine@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Osteoarthritis of the knee with 2 compartments involvement unresponsive to conservative therapy Osteoarthritis of the knee with 3 compartments involvement unresponsive to conservative therapy no limit no limit Both 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 M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery 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.) 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. Pain. Timepoint: Annually. Method of measurement: WOMAC index. Movement of limitation. Timepoint: Annually. Method of measurement: WOMAC index. Physical function. Timepoint: Annually. Method of measurement: WOMAC index. Declared condition. Timepoint: Annually. Method of measurement: نمره OKS. Range of motion. Timepoint: annually. Method of measurement: Physical examination. Joint stability. Timepoint: Annually. Method of measurement: Physical examination. Shahid Beheshti University of Medical Sciences Approved 2022-09-20 Ethics committee of Shahid Beheshti University of Medical Sciences SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)