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IRCT20180408039241N1 IRCT 2019-01-20 Mashhad University of Medical Sciences Investigation of the results of correction of knee varus deformity with two surgical methods in patients with bow legs Investigation and comparison of the results of correction of knee varus deformity with medial open wedge and lateral closed wedge in patients with symptomatic genu varum 2018-09-26 anticipated 76 Complete https://irct.ir/trial/31786 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups. For each group, 38 random numbers are selected from random numbers table and placed in sealed envelopes. Envelopes are given to a specific person, and when a patient refers for surgery, an envelope is opened and based on it, the patient is placed in a specific group. 2-3 Genuvarum. Intervention 1: Intervention group 1: In this group, patients are treated with medial opening wedge osteotomy. Under sterile condition and general anesthesia, incision of medial proximal tibia is carried out and the proximal tibia becomes exposed. Afterwards, on the tibial tuberosity surface, medial proximal osteotomy is carried out and a wedge with appropriate size is placed in location of osteotomy and is fixed using proximal tibia t-plate, 3 proximal and 3 distal screws. Then, drain placement will be done. Intervention 2: Intervention group 2: In this group, patients are treated by lateral closing wedge osteotomy. Under sterile condition and general anesthesia, incision of lateral and proximal tibia is performed. Osteotomy of the head of fibula is carried out while maintaining peroneal nerve. Afterwards, corticotomy of interior tibia with maintaining patellar tendon , corticotomy of medial tibia with maintaining MCL (medial collateral ligament), lateral corticotomy with maintaining LCL (lateral collateral ligament) and posterior corticotomy with maintaining popliteal artery are carried out. Lateral wedge correction is performed using 2 genu varum staples. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Ali Dastjerdi
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 Alidastjerdi555@gmail.com Mashhad University of Medical Sciences scientific Dr Hadi Makhmalbaf
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 makhmalbafh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having significant pain and disability in respect to osteoarthritis Varus deformity Patient's ability to use crutch after operation Good vascular status no limit no limit Both History of internal disease History of fracture in the lower extremity History of surgery in the knee joint Having muscular lesion in the lower extremity Heart failure and varicosis M21.1 Varus deformity, not elsewhere classified Treatment - Surgery Treatment - Surgery Intervention group 1: In this group, patients are treated with medial opening wedge osteotomy. Under sterile condition and general anesthesia, incision of medial proximal tibia is carried out and the proximal tibia becomes exposed. Afterwards, on the tibial tuberosity surface, medial proximal osteotomy is carried out and a wedge with appropriate size is placed in location of osteotomy and is fixed using proximal tibia t-plate, 3 proximal and 3 distal screws. Then, drain placement will be done Intervention group 2: In this group, patients are treated by lateral closing wedge osteotomy. Under sterile condition and general anesthesia, incision of lateral and proximal tibia is performed. Osteotomy of the head of fibula is carried out while maintaining peroneal nerve. Afterwards, corticotomy of interior tibia with maintaining patellar tendon , corticotomy of medial tibia with maintaining MCL (medial collateral ligament), lateral corticotomy with maintaining LCL (lateral collateral ligament) and posterior corticotomy with maintaining popliteal artery are carried out. Lateral wedge correction is performed using 2 genu varum staples. Measuring the amount of pain. Timepoint: Before surgery and 6 months and one year after surgery. Method of measurement: Using the pain rate questionnaire (Visual Analogue Scale). Knee injuries. Timepoint: Before surgery and 6 months and one year after surgery. Method of measurement: Using a simple graph of knee and questionnaire of knee Injury and osteoarthritis outcome score (KOOS). Knee joint range of motion. Timepoint: before surgery and at intervals of 2 weeks, 6 weeks, 3 months, 6 months and one year after surgery. Method of measurement: Clinical examinations. Stability of medial and lateral ligaments. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and one year after surgery. Method of measurement: Clinical examinations. Mashhad University of Medical Sciences Approved 2018-05-30 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)