]>
IRCT20110809007274N18 IRCT 2022-05-09 Rasht University of Medical Sciences Effect two methods of multiple needle puncturing and subperiosteal elevation of MCL undergoing total knee arthroplasty in patients with osteoarthritis with severe varus deformity Comparison of the effect of multiple needle puncturing and subperiosteal elevation of MCL on clinical and radiographic outcomes of patients undergoing total knee arthroplasty in patients with osteoarthritis with severe varus deformity, a double-blind randomization clinical trial 2022-04-30 anticipated 174 Complete https://irct.ir/trial/62980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, according to the estimated sample size, the online site https://www.sealedenvelope.com will be used to generate a randomization list of individuals to study groups. Based on the method of random blocks and considering 29 blocks of 6 for 174 patients into two groups of intervention and control Will be produced by the site. Eligible patients will be Randomly allocationed to two groups: multiple needle puncturing(87 patients) and subperiosteal elevation (87 patients). To ensure blinding, consecutively-numbered sealed envelopes will be used during the randomization process, and the envelope pertaining to each person will be opened only after confirming the candidate’s eligibility and their signing of the consent form, Blinding description: The present study is a double-blind study and the patients under study do not know the type of surgical intervention process. The evaluator will also be an orthopedic assistant who is not present in the treatment process of these patients. 3 Osteoarthritis with severe varus deformity. Intervention 1: Intervention group: Multiple needle puncturing for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity. Intervention 2: Control group: Subperiosteal elevation for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity. 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 Undecided - It is not yet known if there will be a plan to make this available
public dr. Mohsen Mardani-kivi
Poursina Hospital, Poursina Crossroads, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3332 5783 mardani.kivi@gmail.com Rasht University of Medical Sciences scientific dr. Mohsen Mardani-kivi
Poursina Hospital, Poursina Crossroads, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3332 5783 mardani.kivi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Severe varus osteoarthritis knee patients undergoing primary total knee arthroplasty Varus angle of above 15 degrees The age group of 55 years to above Individual consent for participation in the study 55 years no limit Both Any history of knee surgery Valgus knees Bone grafting for a severe deformity or bone defect Rheumatoid arthritis Neuromuscular problems, including severe spinal disease M17.9 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery Intervention group: Multiple needle puncturing for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity Control group: Subperiosteal elevation for release MCL underwent total knee arthroplasty in patients with osteoarthritis with severe varus deformity Knee society score (KSS). Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on KSS questionnaire. Womac score. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on womac questionnaire. Femorotibial angle. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on varus angle(Radiography). Infection. Timepoint: After surgery. Method of measurement: Wound discharge during examination. Hematoma. Timepoint: After surgery. Method of measurement: hematoma after surgery. Deep vein thrombosis (DVT). Timepoint: After surgery. Method of measurement: Incidence of DVT after surgery. Rasht University of Medical Sciences Approved 2022-04-06 Research Ethics Committees of Guilan university of medical sciences Guilan University of Medical Sciences' Headquarters, In front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St.,Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)