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IRCT20240425061571N2 IRCT 2025-03-13 Babol University of Medical Sciences Comparison of 2 surgical methods of ostotomy with and without medial meniscus repair in patients with knee deformity accompanied by medial meniscus injury. Comparison of 2 surgical methods of proximal tibial ostotomy (HTO) with and without medial meniscus repair in patients with varus knee deformity accompanied by medial meniscus injury and its effect on clinical outcomes of patients: A randomized clinical trial study 2025-04-21 anticipated 110 Complete https://irct.ir/trial/82272 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using the permutation block method. In this method, the size of each block will be 4 and the allocation ratio in each block will be 1.1. In this way, each block will have an equal number (2 of each method) of each surgery. The order of surgery will be randomly selected by the methodologist using the sealed envelope.com software. In order to conceal the treatment process, envelopes of the same shape and size will be divided into the number of participants in the study, and the type of surgery will be written inside the envelope. Random codes will be written on the envelopes by the methodologist. When each participant enters the study, the relevant code will be recorded in the patient file. In case of severe complications, the relevant codes will be opened. N/A Osteoarthritis knee. Intervention 1: Intervention group: Osteotomy technique A 6 to 8 cm longitudinal skin incision was made in the anteromedial and proximal tibia from the infrapatella to the distal. After dissection of the subcutaneous tissue, the MCL was separated from the bone and retracted posteriorly. Since the ostotomy point was 4 cm from the joint surface, there was no need to cut the pes anserinus tendons and only if necessary, a 5 mm incision was made and retracted posteriorly. The patellar tendon was identified and protected with a retractor. A 2.4 mm Kirschner wire was inserted under fluoroscopy (C-ARM Fluoroscopy) from the ostotomy entry point on the medial side of the tibia in the anterior third of the tibia, which is 4 cm distal to the joint line, towards the fibular head. The tip of the Kirschner wire was placed 1.5 cm distal to the joint line and 1 cm medial to the lateral cortex. Another Kirschner wire is placed parallel to the previous Kirschner wire in the posterior third of the tibia. After placing 2 Kirschner wires, an osteotomy is performed with a saw, and special attention should be paid to attaching the blade to the wire, and we cut up to 1 cm medial to the lateral cortex, and the next cut is made under the tibial tuberosity at an angle of 110 degrees in a position where the hand is parallel to the ground. After completing the two cuts, we use the LAMINA SPREADER to open the ostotomy site. We open the LAMINA SPREADER opening according to the desired correction angle. Then it is fixed with a 6-hole locking plate. It should be noted that during fixation, there must be a sandbag under the patient's heel and the tip of the LAMINA SPREADER is placed in the posterior third of the tibia. Intervention 2: Intervention group: In addition to the ostotomy surgery below, the patient underwent arthroscopic partial meniscotomy. Osteotomy technique A 6 to 8 cm longitudinal skin incision was made in the anteromedial and proximal tibia from the infrapatella to the distal. After dissection of the subcutaneous tissue, the MCL was separated from the bone and retracted posteriorly. Since the ostotomy starting point was 4 cm from the joint surface, there was no need to cut the pes anserinus tendons and only if necessary, a 5 mm incision was made and retracted posteriorly. The patellar tendon was identified and protected with a retractor. A 2.4 mm Kirschner wire was inserted under fluoroscopy (C-ARM Fluoroscopy) from the ostotomy entry point on the medial side of the tibia in the anterior third of the tibia, which is 4 cm distal to the joint line, towards the fibular head. The tip of the Kirschner wire is placed 1.5 cm distal to the joint line and 1 cm medial to the lateral cortex. Another Kirschner wire is placed parallel to the previous Kirschner wire in the posterior third of the tibia. After placing 2 Kirschner wires, an osteotomy is performed with a saw, and special attention should be paid to attaching the blade to the wire, and we cut up to 1 cm medial to the lateral cortex, and the next cut is made under the tibial tuberosity at an angle of 110 degrees in a position where the hand is parallel to the ground. After completing the two cuts, we use the LAMINA SPREADER to open the ostotomy site. We open the LAMINA SPREADER opening according to the desired correction angle. Then it is fixed with a 6-hole locking plate. It should be noted that during fixation, there must be a sandbag under the patient's heel and the tip of the LAMINA SPREADER is placed in the posterior third of the tibia. Yes - There is a plan to make this available What will be shared: Allowed When: 3 years after publication of the article To whom: Responsible Conditions: Allowed Where to obtain: 3 years How to obtain: Email Comments:
public Yasin Sharifzadeh
Sardar Soleimani
Babol Iran (Islamic Republic of) 4716699118 +98 11 3225 2071 dryasinsharifzadeh@gmail.com Babol University of Medical Sciences scientific Yasin Sharifzadeh
Sheikh Tabarsi St., 14 Sardaran Alley, 2 Nima Alley, Mr. Zamanian's personal house, 3rd floor
Babol Iran (Islamic Republic of) 5157541235 +98 11 3225 2071 dryasinsharifzadeh@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age under 60 years and Lawrence (4) Knee pain and disability due to osteoarthritis that significantly interferes with employment or active recreation Failure to respond to non-invasive treatments such as physical therapy and medication for 3 months Medial meniscus tear based on MRI no limit 60 years Both Narrowing of the lateral compartment cartilage space Lateral tibial subluxation of more than 1 cm Loss of bone in the inner side of the tibia of more than 2 or 3 mm Flexion contracture greater than 15 degrees Knee bending less than 90 degrees More than 20 degrees of correction required Inflammatory arthritis Significant peripheral vascular disease Pregnancy Opioid addiction Diabetes M19.93 Secondary osteoarthritis, unspecified site Treatment - Surgery Treatment - Surgery Intervention group: Osteotomy technique A 6 to 8 cm longitudinal skin incision was made in the anteromedial and proximal tibia from the infrapatella to the distal. After dissection of the subcutaneous tissue, the MCL was separated from the bone and retracted posteriorly. Since the ostotomy point was 4 cm from the joint surface, there was no need to cut the pes anserinus tendons and only if necessary, a 5 mm incision was made and retracted posteriorly. The patellar tendon was identified and protected with a retractor. A 2.4 mm Kirschner wire was inserted under fluoroscopy (C-ARM Fluoroscopy) from the ostotomy entry point on the medial side of the tibia in the anterior third of the tibia, which is 4 cm distal to the joint line, towards the fibular head. The tip of the Kirschner wire was placed 1.5 cm distal to the joint line and 1 cm medial to the lateral cortex. Another Kirschner wire is placed parallel to the previous Kirschner wire in the posterior third of the tibia. After placing 2 Kirschner wires, an osteotomy is performed with a saw, and special attention should be paid to attaching the blade to the wire, and we cut up to 1 cm medial to the lateral cortex, and the next cut is made under the tibial tuberosity at an angle of 110 degrees in a position where the hand is parallel to the ground. After completing the two cuts, we use the LAMINA SPREADER to open the ostotomy site. We open the LAMINA SPREADER opening according to the desired correction angle. Then it is fixed with a 6-hole locking plate. It should be noted that during fixation, there must be a sandbag under the patient's heel and the tip of the LAMINA SPREADER is placed in the posterior third of the tibia. Intervention group: In addition to the ostotomy surgery below, the patient underwent arthroscopic partial meniscotomy. Osteotomy technique A 6 to 8 cm longitudinal skin incision was made in the anteromedial and proximal tibia from the infrapatella to the distal. After dissection of the subcutaneous tissue, the MCL was separated from the bone and retracted posteriorly. Since the ostotomy starting point was 4 cm from the joint surface, there was no need to cut the pes anserinus tendons and only if necessary, a 5 mm incision was made and retracted posteriorly. The patellar tendon was identified and protected with a retractor. A 2.4 mm Kirschner wire was inserted under fluoroscopy (C-ARM Fluoroscopy) from the ostotomy entry point on the medial side of the tibia in the anterior third of the tibia, which is 4 cm distal to the joint line, towards the fibular head. The tip of the Kirschner wire is placed 1.5 cm distal to the joint line and 1 cm medial to the lateral cortex. Another Kirschner wire is placed parallel to the previous Kirschner wire in the posterior third of the tibia. After placing 2 Kirschner wires, an osteotomy is performed with a saw, and special attention should be paid to attaching the blade to the wire, and we cut up to 1 cm medial to the lateral cortex, and the next cut is made under the tibial tuberosity at an angle of 110 degrees in a position where the hand is parallel to the ground. After completing the two cuts, we use the LAMINA SPREADER to open the ostotomy site. We open the LAMINA SPREADER opening according to the desired correction angle. Then it is fixed with a 6-hole locking plate. It should be noted that during fixation, there must be a sandbag under the patient's heel and the tip of the LAMINA SPREADER is placed in the posterior third of the tibia. Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: Four initial assessments will be conducted (at the beginning of the study, after surgery, after 1 and 6 months of surgery). Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Visual Analog Scale - VAS. Timepoint: Before intervention, 6 months after intervention. Method of measurement: Visual Analogue Pain Scale. Joint line convergence angle (JLCA). Timepoint: Before intervention, 6 months after intervention. Method of measurement: by marco pacs software. Posterior tibial slope angle. Timepoint: Before intervention, 6 months after intervention. Method of measurement: by marco pacs software. Hip-knee-ankle (HKA) angle. Timepoint: Before intervention, 6 months after intervention. Method of measurement: three joint view x ray. Babol University of Medical Sciences Approved 2025-03-10 Ethics Committee of Babol University of Medical Sciences Sardar Soleimani St Babol Mazandaran Iran (Islamic Republic of)