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IRCT20191222045857N2 IRCT 2023-08-18 Tehran University of Medical Sciences Comparing the functional results of Persona's medial congruent and posterior-stabilized prostheses in total knee arthroplasty Investigating the functional outcomes of using medial congruent prostheses and comparing its results with Persona's posterior-stabilized prostheses in total knee arthroplasty in patients: A double-blind randomized clinical trial study 2023-10-07 anticipated 80 Complete https://irct.ir/trial/72083 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into control (persona posterior-stabilized prostheses) and intervention (congruent medial prostheses) groups. The randomization of people will be done using the Permuted block randomization method with the random selection of the size of the blocks. Block randomization works by randomizing participants within blocks such that an equal number is assigned to each treatment. For example, given a block size of 4, there are six possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence. Furthermore, the block size must be divisible by the number of study groups. Random Allocation Software 2.0 will be used to generate a random sequence by block method for ease of use and time-saving. A disadvantage of block randomization is that the allocation of participants may be predictable and result in selection bias when the study groups are unmasked. That is, the treatment assignment that has so far occurred least often in the block likely will be the next chosen. Selection bias may be reduced by using random block sizes and keeping the investigator blind to the size of each block, Blinding description: The blinding method in this study is double-blinded, in which the patients, the person responsible for randomization, and the person responsible for data analysis are not aware of the randomization setting of the study. Patients, the person responsible for randomization, and the person responsible for data analysis will only be aware of each person belonging to one of the group's A and B. They will not know which of the intervention or control groups each of the two groups, A and B, represents. Unlike the above people, the surgical team will know which of the intervention or control groups each of groups A and B belongs to. N/A Severe end-stage knee osteoarthritis eligible for TKA surgery. Intervention 1: Intervention group: There are patients in whom knee joint replacement surgery is performed using medial congruent prostheses. This group will have the same pre-operative training, pre-operative evaluations and post-operative care as the control group. Intervention 2: Control group: There are patients in whom knee joint replacement surgery is performed using Persona Posterior-Stabilized prostheses. This group will have the same pre-operative training, pre-operative evaluations and post-operative care as the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Fardis Vosoughi
No.90, Hakhamanesh avenue, Niayesh street, Sattatkhan street
Tehran Iran (Islamic Republic of) 1444995184 +98 21 8827 0873 f-vosoughi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Fardis Vosoughi
Sattarkhan street, Niayesh street, Hakhamanesh avenu, No.90
Tehran Iran (Islamic Republic of) 1444995184 +98 21 8827 0873 f-vosoughi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with severe end-stage osteoarthritis of the knee who are eligible for TKA surgery (painful and disabled knee joint with involvement of one or more compartments) Patients with osteoarthritis resistant to conservative treatment no limit no limit Both Previous hip or ankle replacement Rheumatoid Arthritis Active infections, local or systemic Osteotomy or previous fracture or surgery of the tibia or femur M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery Intervention group: There are patients in whom knee joint replacement surgery is performed using medial congruent prostheses. This group will have the same pre-operative training, pre-operative evaluations and post-operative care as the control group. Control group: There are patients in whom knee joint replacement surgery is performed using Persona Posterior-Stabilized prostheses. This group will have the same pre-operative training, pre-operative evaluations and post-operative care as the intervention group. Alignment of limbs and prostheses. Timepoint: Patients visit the clinic for evaluation at 2, 6, 12 and 6 months of age and then annually after surgery. Knee radiographs including AP and lateral views will be taken. Method of measurement: A long standing radiograph of the knee leg at 3 months after surgery will be used to evaluate the hip-knee-ankle angle (HKA; mechanical axis) of the lower limb, the varus and/or valgus angle of the femur relative to the mechanical axis of the femur. (medial femoral distal angle; MDFA), and the varus and/or valgus angle of a tibial component relative to the mechanical axis of the tibia (medial proximal tibial angle). A lateral radiograph will be used to assess the flexion of the femoral component (femoral flexion angle) and the tilt of the tibial component (tibial tilt). Total surgery time. Timepoint: From skin incision to wound closure from arthrotomy site repair, vacuum drain placement and skin closure. Method of measurement: Based on the time measured by the stopwatch. The total amount of intraoperative bleeding. Timepoint: From skin incision to wound closure from arthrotomy site repair, vacuum drain placement and skin closure. Method of measurement: The amount of blood collected by the suction device. Hb changes. Timepoint: Before and 24 hours after the operation. Method of measurement: CBC, diff. Blood transfusion rate. Timepoint: Hospitalization period. Method of measurement: Counting the number of blood units injected. Improve performance. Timepoint: Weeks 2, 6, 12 and 6 months and 1 year after surgery. Method of measurement: Visual Analog Scale pain score - Knee Injury and Osteoarthritis Outcome Score - Forgotten Joint Score - Range of motion. Complications of surgery. Timepoint: During one year after the operation. Method of measurement: History and examination. Tehran University of Medical Sciences Approved 2023-07-19 Research Ethics Committees of Shariati Hospital - Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)