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IRCT20180528039883N2 IRCT 2021-08-08 Iran University of Medical Sciences optimal area of surgical incision in total knee arthroplasty patients with old scars Evaluation of the optimal area of surgical incision for total knee arthroplasty in patients with old scars 2021-06-21 anticipated 44 Complete https://irct.ir/trial/55718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the participants in the study using inclusion and non-inclusion criteria, to prevent the occurrence of bias in the selection of participants to intervention and control groups, we will use the randomization method to minimize the opinion of researchers in selecting participant to study groups. The block randomization method was used in this study. The size of the blocks is considered to be four and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A and B. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output, Blinding description: After obtaining informed consent and explaining that the selection in each group is done randomly by the program and how each group is done, the participants are divided into two groups without knowing which group they are in Obviously, if any of the participants object, it will be removed from the study list and routine treatment will be performed according to the protocol And the analyzer does not know which group each patient is in. N/A Determining the best area for a total knee arthroplasty surgical incision in patients with an old scar. Intervention 1: Intervention group: Patients who try to total knee arthroplasty regardless of the distance from the scar site with the midline approach. That is, if the previous scar site is not spaced and overlaps with our midline incision, we will continue the midline approach. Campbell's book page 456 The distance between the old and the new incision should be at least 8 cm, but according to the mechanism of fasciomusculocotaneus flap and the method in which it is done, it seems that this amount of distance from the original incision is not necessary Did. Intervention 2: Control group: Patients whose incision distance from the scar is at least 8 cm and is performed according to the book protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made
public Ali Yeganeh
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
Tehan Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6653 9233 yeganeh.a@iums.ac.ir Iran University of Medical Sciences scientific Ali Yeganeh
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
Tehan Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6653 9233 yeganeh.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Candidate for total knee arthroplasty Have an old surgical scar on the knee within the surgical incision area Age over 15 years in pateint no limit no limit Both Patients' dissatisfaction with participating in this research project Treatment - Surgery Treatment - Surgery Intervention group: Patients who try to total knee arthroplasty regardless of the distance from the scar site with the midline approach. That is, if the previous scar site is not spaced and overlaps with our midline incision, we will continue the midline approach. Campbell's book page 456 The distance between the old and the new incision should be at least 8 cm, but according to the mechanism of fasciomusculocotaneus flap and the method in which it is done, it seems that this amount of distance from the original incision is not necessary Did Control group: Patients whose incision distance from the scar is at least 8 cm and is performed according to the book protocol Skin incision healing. Timepoint: Before intervention / One week after intervention / 2 weeks after intervention / One month after intervention. Method of measurement: observation. Research of Iran University of Medical Sciences Approved 2021-03-16 Ethics committee of iran university of medical sciences Tehran Hemat Highway next to Milad Tower، 14535 Tehran Tehran Iran (Islamic Republic of)