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

This study aims to investigate the functional results and postoperative pain in the use of medial congruent (MC) prostheses and compare the results with Persona's posterior-stabilized (PS) prostheses. Our hypothesis is that the use of the MC prosthesis will provide similar functional and postoperative pain results to the PS prosthesis.

Two-arm parallel group randomized double-blind clinical trial on 80 TKA candidate patients from October 1402 to 1404 in Tehran Shariati Hospital with at least one-year follow-up

Tehran Shariati Hospital 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 groups 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 belong to.

Inclusion criteria: - Patients with severe end-stage osteoarthritis of the knee who are eligible for TKA surgery - Patients with osteoarthritis resistant to conservative treatment Exclusion criteria: - Previous hip or ankle replacement - Rheumatoid Arthritis - Active infections, local or systemic - Osteotomy or previous fracture or surgery of the tibia or femur

Patients will be assigned to the following two groups: 1. Medial Congruent 2. Persona Posterior-Stabilized In each group, patients will undergo TKA surgery using the mentioned prostheses. All patients will have the same preoperative education, the same preoperative evaluations, and the same postoperative care protocol.

Alignment of limbs and prostheses; total surgery time; the total amount of intraoperative bleeding; Hb changes; performance improvement; Complications of surgery

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.

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.

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